Testosterone Deficiency And Replacement Therapy In Men

Main Category: Endocrinology
Also Included In: Men’s health;  Erectile Dysfunction / Premature Ejaculation
Article Date: 20 Jul 2011 – 2:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Advertisement

Patient / Public:not yet rated

Healthcare Prof:not yet rated

Article Opinions: 1 posts

Testosterone deficiency (TD), often referred to as hypogonadism, is associated with aging and affects approximately 30 percent of men ages 40-79. To highlight some of the challenges and controversies encountered in diagnosis and treatment of men with TD, the authors of a review article in the American Journal of Medicine introduced a clinical vignette to illustrate the implication of TD on men’s overall health and analyzed a number of studies in men receiving Testosterone Replacement Therapy (TRT) to treat TD. The article also provided an algorithm for diagnosis and treatment and addressed the areas of concern and uncertainty involving testosterone replacement therapy (TRT).

The clinical vignette depicted a 52 year old man of Caucasian descent who presented with erectile dysfunction, diminished libido and fatigue. He was 5 feet, 7 inches tall, weighed 217 pounds and had normal blood and laboratory values, except that his blood pressure was high and his serum total testosterone was low and his fasting serum glucose and lipid profiles were high – indicating the presence of metabolic syndrome.

In conclusion, the authors recommend that the man be treated for 2-3 months using TRT, with a follow up to determine the efficacy of the TRT in increasing his testosterone levels to normal levels. Their recommendations are in agreement with many published guidelines and show that the TRT treatment, in conjunction with diet and exercise, will help improve the man’s sexual and physical health.

“This clinical vignette offers important information for general practitioners and provides practical recommendations for diagnosing TD and the novel treatment approaches that could positively impact the overall health of middle-aged men,” said Traish.

By introducing the clinical vignette as a teaching case study the authors re-focused the attention on utilizing not only blood (serum) test for testosterone, but also taking into account the sexual and non-sexual physical symptoms into considerations. The authors also indicated that current data failed to show a significant association between TRT and prostate cancer. TRT has been shown to improve sexual function in men with TD. According to a recent review article in the American Journal of Medicine, TRT might also improve the overall health of men.

Abdulmaged M. Traish, MBA, PhD, professor of Urology and Biochemistry at Boston University School of Medicine (BUSM), is the lead author of the article, which was written as a concise review for primary care physicians about advancements being made in the field of endocrinology and men’s health. This article was written in collaboration with Martin M. Miner, MD, from the Warren Albert School of Medicine at Brown University; Abraham Morgentaler, MD, from Beth Israel Deaconess Medical Center; and Michael Zitzmann, MD, from the University Clinics Muenster, Germany.

Source:
Jenny Eriksen Leary

Boston University Medical Center



Advertisement



Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Endocrinology headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Testosterone And Hemoglobin

posted by Tom on 20 Jul 2011 at 7:21 am

One might think to be totally safe one might include a vignette which depicts the use of erythropoietin in kidney patients / metabolic syndrome. When THEIR hemoglobin was raised into ‘normal’ they tended to DIE. Testosterone raises red blood cells. Erythropoietin raises red blood cells. IF the body itself is KEEPING the testosterone low in order to regulate red blood cells then artificially raising it might be bad ?
“Effects of Graded Doses of Testosterone on Erythropoiesis in Healthy Young and Older Men”
“Hemoglobin and hematocrit increased significantly in a linear, dose-dependent fashion in both young and older men in response to graded doses of testosterone”

| post followup | alert a moderator |


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

VIVUS Submits New Drug Application For Avanafil For The Treatment Of Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 01 Jul 2011 – 1:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

VIVUS, Inc. (NASDAQ: VVUS) announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED.

“This NDA filing is yet another major milestone for VIVUS and the avanafil program. The efficacy was consistent across all patient groups, with success observed in some patients in as early as 15 minutes after dosing. The drug was well tolerated and had a low dropout rate in all of the clinical trials. If approved, avanafil could be an attractive treatment alternative for the 30 million men in the United States who suffer from ED,” stated Leland F. Wilson, chief executive officer for VIVUS. “The unique profile of potentially faster onset and greater selectivity should allow avanafil to effectively compete in the $4 billion worldwide ED market. I wish to thank all of the VIVUS employees, investigators, advisors, patients and our development partner, Mitsubishi Tanabe Pharma Corporation, who contributed to the program and made this filing possible.”

The NDA includes results from two placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, and REVIVE-Diabetes, which included 390 diabetics. Also included are the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies. Previously reported highlights from the avanafil development program include:

— All doses tested 50 mg, 100 mg, and 200 mg met each of the co-primary efficacy endpoints of the studies

— Erections sufficient for penetration (SEP2) were observed in 77% and 63% of avanafil patients at the 200 mg dose, as compared to 54% and 42% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively

— Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients at the 200 mg dose, as compared to 27% and 20% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively

— Significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients

— Across all the phase 3 studies, successful intercourse (SEP3) was observed in some avanafil-treated patients as early as 15 minutes after dosing

— The most common side effects were headache, flushing, nasopharyngitis and nasal congestion

— There were no drug-related serious adverse events reported in the studies

About the Avanafil Phase 3 Program

The avanafil phase 3 program consists of three pivotal studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes) and TA-303 (REVIVE-RP), as well as a 52-week, open-label, long-term safety study. TA-301, TA-302 and TA-303 were all randomized, double-blind, placebo-controlled phase 3 studies of avanafil in patients with a history of ED for at least six months. Each of the pivotal trials has a similar trial design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment. Primary endpoints of the studies are improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF). REVIVE-RP was not required for the NDA filing.

Source: VIVUS, Inc




Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Erectile Dysfunction / Premature Ejaculation headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

MHRA Warns About Dangerous ‘Herbal’ Treatments For Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Complementary Medicine / Alternative Medicine
Article Date: 01 Jul 2011 – 2:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

Unlicensed herbal remedies for erectile dysfunction, available over the internet, could present serious health risks according to recent test results received by the MHRA.

The MHRA received advice from the Federal Agency for Medicines and Health Products in Belgium as well as the Food and Drug Administration (FDA) in the USA on ‘Africa Black Ant’, ‘Rock Hard Weekend’, ‘Pandora’ and ‘The Best’.

These unlicensed products were found to contain the Prescription Only Medicine (POM) sildenafil, which should only be used when prescribed by a doctor and could cause potentially life-threatening high blood pressure.

The products have been marketed over the internet as a ‘herbal supplement’. However, consumption of sildenafil in unknown or uncontrolled quantities could be extremely dangerous and cause serious adverse reactions such as heart attacks and strokes.

MHRA Head of Herbal Policy Richard Woodfield said: “Historically, with unlicensed herbal medicines, people have needed to be aware that the standards could vary widely and sometimes be poor.

“However, an increasing range of herbal medicines made to assured standards are now available on the UK market thanks to the Traditional Herbal Registration (THR) scheme.”

Registered and licensed herbal medicines can be identified by the THR logo or the product licence (PL) number on the label.

The scheme has been designed so that the public will no longer have to guess at the safety and quality of herbal medicines.

Mr Woodfield added: “In the UK, certain medicines are categorised as POM due to their potent nature, so they should only be used under the care and supervision of suitably qualified healthcare professionals. “The unlawful sale of products posing as ‘herbal’ but containing POMs is a serious threat to public health and could be dangerous. Anyone with information about the sale or supply of products such as these should notify us immediately.”

Any side effects of herbal products can be reported to the MHRA via the Yellow Card Scheme.

Notes

1. ‘Africa Black Ant’ comes in red and black packaging and is promoted as a natural dietary supplement or herbal Viagra for erectile dysfunction.

2. ‘Rock Hard Weekend’ and ‘Pandora’ capsules come in blister packs and bottles and are marketed as sexual enhancers for men and women.

3. ‘The Best’ is a male sexual enhancer and comes in yellow and red packaging with single blister capsules. It is promoted as a herbal Viagra for erectile dysfunction.

4. Members of the public are advised that they should only take Prescription Only Medicines after an appropriate consultation with their GP. Only healthcare professionals can take into account risks and benefits associated with every medicine.

5. The Traditional Herbal Registration (THR) certification mark is a type of trade mark. It indicates that the herbal medicine has been registered with the MHRA under the THR scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC (external link). Under this scheme, the permitted indications for the medicine are based on traditional usage and not on evidence of effectiveness of the product.

Source:

MHRA




Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Erectile Dysfunction / Premature Ejaculation headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Poor Oral Care May Cause Sexual Problems

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Dentistry;  Sexual Health / STDs
Article Date: 29 Jun 2011 – 3:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

A recent study has revealed erectile dysfunction can be linked to gum disease.

The research1, carried out on 70 male subjects, showed a correlation between gum disease and the ability to achieve an erection. The data indicates that as the severity of erectile dysfunction increased, so did the prevalence of chronic periodontitis (gum disease). Overall, more than four out of five men (81.8 per cent) with severe erectile dysfunction had gum disease. In comparison, in cases of mild erectile dysfunction, the incidence of gum disease was less than two in five men.

According to the National Institutes of Health2, erectile dysfunction is defined as the inability to attain and or maintain an erection sufficient for satisfactory sexual performance. It is a condition that affects one in 10 men worldwide, and is more commonly experienced after the age of 403.

Chief Executive of the British Dental Health Foundation, Dr Nigel Carter, believes the stigma attached to the subject could be forcing men up and down the country to turn a blind eye on their oral health.

Dr Carter said: “To associate gum disease, the major preventable cause of tooth loss in adults, with such a taboo subject amongst males is not something that should be taken lightly. If, in theory, four out of five men who suffer from erectile dysfunction have poor oral health, the effect it could have on their general health poses a serious health risk to those individuals affected.

“It is a well-known fact that gum disease has been linked to many conditions in the past that can have a detrimental effect on your general health such as heart disease and diabetes. When people have gum disease, bacteria from the mouth can get into their bloodstream, so it should therefore come as no surprise that this piece of research has linked vascular erectile dysfunction, another cardiac-related condition, with gum disease.

“The best way to combat oral health problems is to think prevention and develop a good routine to keep your teeth and gums healthy at home. By brushing for two minutes twice a day using a fluoride toothpaste, by reducing the frequency of how often you have sugary foods and drinks and by visiting your dentist regularly, as often as they recommend and by interdental brushing, you stand a far greater chance of having good oral health.”

For men who experience erectile dysfunction and resulting anxiety, loss of self-esteem, lack of self-confidence, tension and difficulty in the relationship with their partner, the message is simple. Dr Carter said: “As the findings of this study suggests, looking after your gums and oral health in general can reduce this risk and in turn offer better quality of life.”

Notes

1. Pradeep, A R., Sharma Anuj., and Arjun Raju P. (2011). Association Between Chronic Periodontitis and Vasculogenic Erectile Dysfunction, Journal of Periodontology, 0:0, 1-7.

2. National Institutes of Health Consensus Development Panel on Impotence. Impotence. JAMA 1993; 270: 83-90.

3. Krane RJ, Goldstein I, Saenz de Tejada I. Impotence. N Engl J Med 1989; 321: 1648-59.

Source:

British Dental Health Foundation




Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Erectile Dysfunction / Premature Ejaculation headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

New Delivery System For Viagra Ingredient

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Heart Disease;  Dermatology
Article Date: 22 Jun 2011 – 8:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

Scientists are reporting development and successful initial tests of a potential new delivery system for the biological signaling agent responsible for the effects of Viagra. It could be used to deliver the substance, called nitric oxide or NO, to treatment conditions ranging from heart disease to skin ulcers and other wounds that fail to heal, according to a report in the Journal of the American Chemical Society.

João Rocha and colleagues explain that NO acts as an important agent in the body for expanding blood vessels (its role in Viagra and related medicines for erectile dysfunction), preventing the formation of blood clots, aiding nerve signals, and repairing wounds. NO’s multipurpose role makes it an exciting prospect for new drug development, but current NO delivery systems sometimes cause undesirable side effects. “Clearly, new materials and technologies are needed to store and target-deliver NO in biological amounts,” the report notes.

The researchers developed a highly absorbent material that can carry varying amounts of NO. The material slowly releases NO at a rate that is useful for treating diseases, they conclude. More work must be done to calculate the “shelf life” of the material loaded with NO, Rocha and colleagues note, but they conclude: “This work is a first step toward assessing the real potential therapeutic applications of these materials.”

The authors acknowledge funding from the Fundo Europeu De Desenvolvimento Regional, Fundo Social Europeu, and the Fundação para a Ciência e a Tecnologia.

Source:
Michael Bernstein

American Chemical Society




Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Erectile Dysfunction / Premature Ejaculation headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Fenugreek Not Just For Your Curry; Improves Male Libido Too

Editor’s Choice
Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Men’s health
Article Date: 20 Jun 2011 – 11:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions
<!– rate icon rate article


Patient / Public:not yet rated

 

Healthcare Prof:not yet rated

 

Fenugreek for sexual enhancement? Yes. A new study from down under in Australia represents the power of the curry spice to improve male libido and also is key in increasing milk supplies in mothers with newborns. The research, performed by the Centre for Integrative Clinical and Molecular Medicine, showed that men who took a fenugreek extract twice daily saw significant improvements in their love life.

The study looked at the effects of a fenugreek-based preparation on the libido of men aged 25 to 52. The men took the extract twice a day for six weeks, while another group had a placebo pill. Within six weeks of starting the trial, men who took the fenugreek had increases in their libido scores of more than 25%.

It is still not known how it works, but it certainly does. Fenugreek does contain some compounds that may affect hormone levels. The compounds, known as saponins, may be responsible for an increase in the production of sex hormones.

New mothers often take fenugreek to increase the volume of breast milk they produce. Other people swear that fenugreek reduces inflammation and wards off arthritis. Still other research shows that the herb can reduce cholesterol levels and perhaps help folks with type-1 and type-2 diabetes manage their symptoms.

Fenugreek seeds contain hormone precursors that increase milk supply. Scientists do not know for sure how this happens either. Some believe it is possible because breasts are modified sweat glands, and fenugreek stimulates sweat production. It has been found that fenugreek can increase a nursing mother’s milk supply within 24 to 72 hours after first taking the herb. Once an adequate level of milk production is reached, most women can discontinue the fenugreek and maintain the milk supply with adequate breast stimulation.

Many women today take fenugreek in a pill form (ground seeds placed in capsules). The pills can be found at most vitamin and nutrition stores and at many supermarkets and natural foods stores. Fenugreek can also be taken in tea form, although tea is believed to be less potent than the pills and the tea comes with a bitter taste that can be hard to stomach.

Be aware however that fenugreek is not right for everyone. The herb has caused aggravated asthma symptoms in some women and has lowered blood glucose levels in some women with diabetes.

Fenugreek is a native to India and southern Europe. For centuries it has grown wild in India, the Mediterranean and North Africa where it is mainly cultivated. A limited crop grows in France. It was used by the ancient Egyptians to combat fever and grown in classical times as cattle fodder. Commercially, it is used in the preparation of mango chutneys and as a base for imitation maple syrup.

In India it is used medicinally, and as a yellow dyestuff. It is also an oriental cattle fodder and is planted as a soil renovator. In the West, fenugreek’s therapeutic use is now largely confined to the treatment of animals, though historically it has been used in human medicine. The name derives from the Latin ‘Greek hay” illustrating its classical use as fodder.

Sources: The Encyclopedia of Spices and The University Queensland School of Medicine

Written by Sy Kraft

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today




Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

Follow us on Twitter
news icon  Erectile Dysfunction / Premature Ejaculation headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

 

Positive Results From Avanafil Post-Prostatectomy Study Featured At Cancer Survivorship Meeting

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 18 Jun 2011 – 0:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article

Patient / Public:not yet rated

Healthcare Prof:1 star

1 (1 votes)

VIVUS, Inc. (Nasdaq: VVUS) announced that the positive results from REVIVE-RP (TA-303), a phase 3 clinical trial evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED),will be presented this afternoon at the 2011 Cancer Survivorship and Sexual Health Symposium in Washington D.C. The meeting is jointly sponsored by the International Society for Sexual Medicine (ISSM) and the Sexual Medicine Society of North America (SMSNA). John Mulhall, M.D., Director of the Male Sexual Reproductive Medicine Program at the Memorial Sloan Kettering Cancer Center in New York, will present the results during the peer-reviewed, moderated poster session.

Avanafil met all primary endpoints by demonstrating improvements from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP 2 and SEP 3) and improvement in the erectile function domain of International Index of Erectile Function (IIEF). The study also indicated a favorable safety profile and successful intercourse (as measured by SEP 3) was observed as early as 15 minutes after dosing, without any restrictions on food or alcohol.

“Patients who have undergone a radical prostatectomy (RP) often have severe erectile dysfunction. Despite advancements in surgery, it can take several months or years to normalize erections. RP patients are difficult to treat but the positive results of avanafil in these patients suggest that, if approved, avanafil could be an attractive treatment option for these patients,” commented Dr. Mulhall. “I am pleased to be presenting these positive results with the health professionals attending the Cancer Survivorship Meeting. The safety and efficacy demonstrated in this trial may offer hope to patients who have been unable to return to normal erectile function following their surgery.”

Highlights of the TA-303 study include:

— Treatment with both doses of avanafil (100 mg and 200 mg) was associated with significant improvements in each of the co-primary endpoints, SEP2, SEP3 and IIEF-EF in comparison with placebo (p

— Patients treated with 100 mg and 200 mg of avanafil improved their ability to have successful intercourse (SEP3) four- and five-fold, respectively, from the start of treatment

— Treatment with avanafil improved erectile function in a dose-dependent manner with significant increases in the IIEF scores from the beginning of treatment through the end of treatment. Erectile function scores increased 38% and 55% for patients on the 100 mg and 200 mg doses, respectively, as compared to the placebo group with an increase of 1%

— The most commonly reported side effects in patients taking avanafil included headache, flushing, and nasopharyngitis

— There were no serious adverse events or deaths reported in the study

About the Study

TA-303 was a randomized, double-blind, placebo-controlled, parallel group, multicenter study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral, nerve-sparing, radical prostatectomy in 298 men with ED. On average, subjects entering the study were 58 years old, 19 months past their surgery dates with documented severe ED. Subjects were randomized to 100 mg or 200 mg avanafil or placebo and were instructed to take one dose of study drug 30 minutes prior to initiation of sexual activity. The study had a four-week run-in period followed by 12 weeks of treatment. The primary endpoints of the study were improvements in erectile function as measured by the SEP2 and SEP3 and improvement in the EF-Domain of the IIEF score; secondary endpoints included patient satisfaction with erections and with sexual experience.

About the Avanafil Phase 3 Program

The avanafil phase 3 program consists of three studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes), and TA-303 (REVIVE-RP) and a 52-week, open-label, long-term safety study (TA-314). TA-301, TA-302 and TA-303 were all randomized, double-blind, placebo-controlled phase 3 studies of avanafil in 646, 390, and 298 men respectively with a history of ED for at least six months. Each of the pivotal trials had a similar trial design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment. Primary endpoints of the studies were improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF). In all three studies, all doses of avanafil tested met the primary endpoints, with successful intercourse achieved by some subjects in 15 minutes or less after administration.

TA-314 evaluated avanafil for up to 52-weeks in 712 men, 486 with a history of ED and 226 diabetic men with ED across 40 centers throughout the U.S. Patients completing REVIVE (TA-301) or REVIVE-Diabetes (TA-302) were eligible for rollover into TA-314. The study met all primary endpoints by demonstrating sustained improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP 2 and SEP 3) and improvements in the International Index of Erectile Function (IIEF). The study also indicated a favorable side effect profile and successful intercourse (as measured by SEP 3) in as little as 15 minutes and beyond six hours after dosing, without any restrictions on food or alcohol intake.

VIVUS held a pre-NDA meeting with the FDA to confirm that the pre-clinical and clinical requirements necessary for the filing of an NDA have been met. In total, the phase 3 avanafil clinical program enrolled approximately 1,350 subjects. VIVUS expects to file the NDA for avanafil in the second quarter of 2011.

Source: VIVUS, Inc




Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Erectile Dysfunction / Premature Ejaculation headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

Older Men More Likely To Lose The Ability To Orgasm Due To Gabapentin

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Seniors / Aging;  Pain / Anesthetics
Article Date: 05 Jun 2011 – 3:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  
<!– rate icon rate article


Patient / Public:not yet rated

Healthcare Prof:not yet rated

Boston University School of Medicine (BUSM) researchers have found that Gabapentin, (trade name Neurontin) a medication commonly used to treat neuropathic pain, seizures and biopolar disease in older and elderly patients, seems to have a higher incidence of anorgasmia, or failure to experience orgasm, than previously reported. This study appears in the current issue of the American Journal of Geriatric Pharmacotherapy.

Anticonvulsants are the fastest growing prescribed medication in the baby boomer generation. In patients 44-82 years old, anticonvulsants are more commonly prescribed than opioids. Gabapentin is a preferred medication, given its perceived benign side effects, typically limited to somnolence and dizziness that resolve with time.

Since its introduction in 1993, only 10 cases of anorgasmia have been reported, mostly in younger patients with an average age of 38 years. In this case study, three of the 11 patients who were over the age of 50 experienced anorgasmia. These male patients were 73, 76 and 78 years old. Interestingly, another case in a 59-year-old female was noted by colleagues at Tufts Medical Center.

“This is a much higher incidence than was reported in the original clinical trials. Gabapentin induced anorgasmia may be more common in older patients,” according to lead author Michael D. Perloff, MD, PhD, an assistant professor neurology at BUSM. “Further, anorgasmia appears to be dose dependent. In all cases orgasm returned when Gabapentin was reduced or stopped.”

The researcher recommends that clinicians should review the potential for anorgasmia with patients taking Gabapentin or discuss it at follow up. “If anorgasmia does occur, patients should be reassured that it is reversible and likely dose dependent,” added Perloff.

Source:
Gina DiGravio

Boston University Medical Center




Bookmark and Share

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
professional. For more information, please read our terms and conditions.

  Follow us on Twitter
news icon  Erectile Dysfunction / Premature Ejaculation headlines
email icon  email to a friend
printer icon  printer friendly version
newsletter icon  weekly newsletter
star icon  personalize your news

back to top - icon  back to top


Please note that we publish your name, but we do not publish your email address. It is only used to let
you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

MediLexicon International Ltd Logo

Privacy Policy |
Terms and Conditions


MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.