Sex Information & HelpSex Information & HelpSex Information & Help

Information and Help about Sexuality and its problems

Home  |  About Us  Links  |  Articles  |  Questions & Answers  |  Resources | Disclaimer

> More News

Viagra for women? Drug developed as antidepressant effective in treating low libido

 The drug flibanserin, which was originally created as an antidepressant, is effective in treating women with low libido, pooled results from three separate clinical trials have found.

These trials were the first ever to test a therapy that works at the level of the brain to enhance libido in women reporting low sexual desire, said John M. Thorp Jr., M.D., McAllister distinguished professor of obstetrics and gynecology at the University of North Carolina at Chapel Hill School of Medicine and the principal investigator for North America in the studies.

“Flibanserin was a poor antidepressant,” Thorp said. “However, astute observers noted that it increased libido in laboratory animals and human subjects. So, we conducted multiple clinical trials and the women in our studies who took it for hypoactive sexual desire disorder reported significant improvements in sexual desire and satisfactory sexual experiences.

“It’s essentially a Viagra-like drug for women in that diminished desire or libido is the most common feminine sexual problem, like erectile dysfunction is in men,” Thorp said.

Studies have shown that the prevalence of hypoactive sexual desire disorder in the U.S. ranges from 9 percent to 26 percent of women, depending on age and menopausal status. Flibanserin is currently an investigational drug and is available only to women taking part in clinical trials.

The results reported here were presented Monday, Nov. 16, at the Congress of the European Society for Sexual Medicine in Lyon, France. The presentation was given by Elaine E. Jolly, M.D., overall principal investigator and a professor at the University of Ottawa in Canada.

 Jolly, Thorp and colleagues pooled data from four clinical trials of flibanserin conducted in the U.S., Canada and Europe. A total of 1,946 pre-menopausal women ages 18 and older were randomized to receive either flibanserin or placebo for 24 weeks, with 4 weeks of pre-treatment baseline measurement and 4 weeks of post-treatment follow-up.

Initially, four different dosing regimens were used in the trials: 25 milligrams twice a day, 50 milligrams once a day at bedtime, 50 milligrams twice a day and 100 milligrams once a day at bedtime. The dosing regimens totaling 50 milligrams a day were not effective while the regimens totaling 100 milligrams were.  So, the results being reported are from only three of the four trials and are based on the 100 milligrams once a day dosing regimen only.

The trials measured mean changes from baseline on the following six variables as reported by the women each week: number of satisfying sexual events (SSE), electronic diary (eDiary) desire score, female sexual function index (FSFI) desire domain score, FSFI total score, female sexual distress scale-revised (FSDR-R), and FSDR-R Item 13 (which focuses specifically on desire/libido).

The researchers concluded that treatment with 100 milligrams of flibanserin once a day was associated with significant improvements versus placebo in the number of satisfying sexual events (SSE) reported, sexual desire (as measured by eDiary and FSFI desire domain), a reduction in distress associated with sexual dysfunction (as measured by FSDS-R and its Item 13), and sexual functioning as measured by FSFI.

“These results point to a novel approach to pharmacologic treatment of the sexual problem that plagues reproductive age women the most, and may over time prove to be an effective treatment without the side effects of androgen replacement therapy, which is the only treatment currently available,” Thorp said.

The trials were funded by Boehringer Ingelheim Pharmaceuticals, the manufacturer of flibanserin.


Cervical cancer link to early sex

Having sex at an early age has been linked with double the risk of developing cervical cancer.

An investigation into why poorer women have a higher risk of the disease found they tended to have sex around four years earlier than more affluent women.

It had been thought that the disparity was due to low screening uptake in poorer areas, but the study found this was not the most important factor.

The latest findings are published in the British Journal of Cancer.

Although the difference in cervical cancer incidence between rich and poor - across the world - had been noted for many years, it was not clear why this is the case.

Especially as rates of infection with human papillomavirus (HPV) - the sexually transmitted infection linked with the vast majority of cervical cancers - seemed to be similar across all groups.

The study, by the International Agency for Research on Cancer, of nearly 20,000 women, confirmed that the higher rates of cervical cancer were not linked to higher HPV levels.

Although women can be infected by HPV at any age, infections at a very young age may be especially dangerous as they have more time to cause damage that eventually leads to cancer.

But what it did reveal is that the two-fold increased risk was largely explained by women from poorer backgrounds starting to have sex at a younger age.

The age at which a woman had her first baby was also an important factor.

Screening was found to have some effect on the level of risk.

But the number of sexual partners a woman has and smoking did not account for any of the difference.

Study leader, Dr Silvia Franceschi, said the findings were not restricted to adolescence and the risk of cervical cancer was also higher in women who had their first sexual intercourse at 20 rather than 25 years.

"In our study, poorer women had become sexually active on average four years earlier.

"So they may have also been infected with HPV earlier, giving the virus more time to produce the long sequence of events that are needed for cancer development."

Dr Lesley Walker, director of cancer information at Cancer Research UK, said the study raised some interesting questions.

"Although women can be infected by HPV at any age, infections at a very young age may be especially dangerous as they have more time to cause damage that eventually leads to cancer.

"Importantly, the results back up the need for the HPV vaccination to be given in schools at an age before they start having sex, especially among girls in deprived areas."

Source: BBC news, 21 December 2009

Desire Drug May Prove Sex Really Is All in Her Head


Boehringer Ingelheim GmbH is banking on sex really being all in women’s heads.

The German drugmaker is putting the finishing touches on a pill designed to reawaken desire by blunting female inhibitions. Unlike Viagra, which targets the mechanics of sex by boosting blood flow to the penis, this drug works on the brain.

The desire drug, the focus of a meeting on sexual disorders in Lyon next week, has the potential to revolutionize sexual medicine much as Pfizer Inc.’s blue pill did a decade ago. That could put family-owned Boehringer at the center of a debate about whether the medicine is a chemical shortcut around a complex dysfunction involving body and mind -- or whether disinterest in sex is a legitimate medical condition.

“This drug has the potential to finally open the door to acceptance of the idea that decreased desire can be something that involves a dysfunctional way the brain works, and not only a bad partner,” said Jim Pfaus, a neurologist at Concordia University in Montreal, who conducted early tests of the drug in rats. “Of course it’s in your head.”

The U.S. market for medicines to rekindle female libido could be bigger than the $2 billion a year in U.S. sales for erectile dysfunction treatments because more women report sexual problems, BioSante Pharmaceuticals Inc. Chief Executive Officer Stephen Simes estimated last year.

Showing It Works

Boehringer, based in the German town of Ingelheim on the Rhine’s west bank, was searching for a depression treatment in the 1990s when it stumbled on the compound, called flibanserin. By 2002, Boehringer found the drug wasn’t lifting patients’ mood. The company says researchers were startled when test subjects rated one measure of well-being, sexual appetite, consistently higher than the others.

After what Pfaus described as an initial period of hesitation about developing a sex pill, Boehringer decided to move forward. The company needs new drugs because it faces the loss of 1 billion euros ($1.5 billion) in annual revenue when two older medicines, Mirapex for Parkinson’s disease and Flomax to treat enlarged prostate, lose patent protection next year.

The world’s largest closely held pharmaceutical company has been studying flibanserin for more than a decade and it has yet to publish clinical test results showing the drug is effective. The company will lift its veil of secrecy on Monday at the European Society for Sexual Medicine conference with data from trials of more than 5,000 European and U.S. women.

Women’s Distress

The main criterion for the clinical trials, which the company named after flowers, was how many “satisfying sexual events” women said they had experienced after starting treatment. If the results are good, the so-called Bouquet studies, dubbed Violet, Daisy, Dahlia and Orchid, could form the basis for applications to U.S. and European regulators.

The German company is taking a page from Pfizer’s book. The U.S. drugmaker broadened the appeal of Viagra in 1998 by steering clear of the word “impotence” and saying the blue pill addressed a disease called erectile dysfunction. Boehringer is avoiding potentially offensive words such as frigidity and refers to the problem its pill cures by its clinical name, hypoactive sexual desire disorder, or HSDD.

“An increasing body of evidence shows that hypoactive sexual desire disorder causes substantial emotional distress,” said Heike Specht, a spokesman for the company. The drugmaker “has conducted late-stage clinical trials in over 5,000 women from which we hope will result the first available pharmaceutical treatment.”

A Boehringer survey of 31,000 U.S. women aged 18 and above found that one in 10 expressed distress because of diminished sex drive.

Ideological Battle

A sluggish libido is “a real problem,” and early clinical results so far suggest Boehringer’s drug can help, according to Stephen Stahl, a psychopharmacologist and chairman of the Neuroscience Education Institute in Carlsbad, California. Stahl, who has been a consultant for Boehringer, sees a growing role for drugs in treating sexual disorders.

Not everyone agrees there is a disorder to begin with.

In 2003, a year after Boehringer started the Bouquet clinical trials, an article written by Ray Moynihan in the British Medical Journal called female sexual dysfunction “the freshest, clearest example we have” of a disease created by pharmaceutical companies to make healthy people think they need medicine.

“This is for some an ideological battle,” said psychiatrist Michael Berner of theFreiburg University Clinic, who had patients in Boehringer’s studies. “One view is the multi-dimensional view you get from people like me. And then you have these people that say you should work only on relationship issues and that medication cannot have a place.”

‘Like Dancing’

Researchers don’t know why some women’s libido falters, said Pfaus, who has tested compounds in rats for Pfizer, Boehringer and Palatin Technologies Inc. by gauging whether they spur female rats to solicit sex from males.

“An erection is obvious, it’s easy,” Pfaus said. “But desire -- how do you get at that?”

The explanation may be partly evolutionary, according to Berner, who says male primates are driven by a need to spread their semen, while for females it’s important to be able to care for and rear the offspring.

Some researchers believe the social components of intercourse mean that sexual problems can’t be addressed in the same way as heart failure or cancer.

Sex is a “historical and cultural phenomenon,” said Leonore Tiefer, a psychiatry professor at New York University. There’s no baseline of normalcy by which to define a disorder, she contends.

“It’s like dancing, or music, or piano-playing,” Tiefer said. “You do it with the body, but the part the body plays isn’t the largest part.”

Over the Wall

Flibanserin works on the brain by putting “two feet on the brakes” to block the release of a chemical called serotonin, which regulates mood, appetite, sleep and memory, Pfaus said. In time, the process should trigger the production of dopamine, a chemical that, among other jobs, helps stimulate desire.

The drug differs from testosterone, a hormone that’s also been tested to reawaken women’s desire. Berner, interviewed at his study in Freiburg, sketched the picture of a wall to explain how flibanserin works.

“You’re standing here, sad, inhibited,” he said, drawing a stick figure next to the wall on a scrap of paper. “Testosterone would give you a little bit more excitement, so you’d climb over. Flibanserin would take away one of the stones.”

Once a Day

The compound takes three to six weeks to kick in. The pill has to be taken daily, and some women taking part in the clinical trials reported feeling tired, Berner said.

Boehringer recruited women for clinical studies using print advertisements. Berner said his patients were largely professionals in their early 30s to mid-40s, and most chose to continue in the trial in a subsequent phase that ensured they would get the real drug instead of a placebo. Boehringer is recruiting older women for a follow-up study.

Women can be diagnosed with hypoactive sexual desire disorder if they feel concerned, bothered or frustrated by a lack of desire -- or if it’s hurting their relationships.

The company used personal digital assistants to check whether the pill was working. Participants were beeped once a day and asked to rate their level of desire and say whether they had been sexually active and whether it was enjoyable.

Potential Rivals

If flibanserin makes it to market, it will be the first success after a series of failures from drugmakers including Procter & Gamble Co. and Pfizer. The New York-based maker of Viagra abandoned efforts to adapt its pill for women in 2004 and closed sex-health research at the end of last year.

The only female sexual dysfunction therapy approved in the U.S. is Eros-CTD, from NuGyn, Inc., a suction pump that fits over the clitoris much like the erection pumps that predated Viagra. Intrinsa, a testosterone patch from Noven Pharmaceuticals Inc. licensed by Procter & Gamble, is sold in Europe for women whose uteruses have been removed. A U.S. version was put on hold in 2004 on concern about whether it is safe for long-term use.

Still in clinical trials are a new version of the P&G patch; LibiGel, a testosterone gel from BioSante; and bremelanotide, an injected therapy from Palatin Technologies.

Researchers around the world will be watching Boehringer’s results in Lyon, according to Pfaus. “There are probably a lot of companies holding their breath,” he said.


The First Potential Treatment For Premature Ejaculation

At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora" AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).

Results of the double-blind treatment phase of this study, which enrolled patients from the U.S., Canada and Poland, are consistent with previously reported results of the pivotal trial conducted in Europe and showed that men who were treated with PSD502 five minutes before intercourse were able to delay ejaculation up to five times longer than those who used placebo.

Additionally, patients and partners in both trials reported significant improvements in sexual satisfaction, and the drug was well tolerated.

An estimated one-third of U.S. men ages 18 - 59 are affected by PE, making it twice as prevalent as erectile dysfunction. Currently, there are no prescription therapies approved in the U.S. to treat PE.

PSD502, a product in development for the treatment of PE, is a proprietary formulation of the two marketed drugs lidocaine and prilocaine dispensed by a metered dose aerosol. PSD502 works selectively on non-keratinized skin on the glans penis (head of the penis).

"Premature ejaculation can have a powerful negative impact on the emotional and sexual lives of men and their partners," said Professor Stanley E. Althof, PhD, Center for Marital and Sexual Health of South Florida, West Palm Beach, Florida.

"Recently, the international sexual health community agreed that PE should be defined as ejaculation occurring within approximately one minute of penetration that causes the patient distress. Now we need to work to develop treatments, and these encouraging results with PSD502 seem to be a step in the right direction."

Both pivotal trials showed clinically and statistically significant efficacy in the treatment of premature ejaculation, as measured by changes in Intravaginal Ejaculatory Latency Time (IELT) and Index of Premature Ejaculation (IPE), a patient-reported outcome of ejaculatory control, sexual satisfaction, and distress.

"We are excited that results from two pivotal studies have shown that PSD502 was effective for men with PE, and we look forward to the opportunity to help patients who have had no real options to date," said Patrick Fourteau, Chief Executive Officer of Sciele Pharma, Inc.

"This data will support the New Drug Application for PSD502 that we are planning to submit to the U.S. Food & Drug Administration (FDA), which upon FDA approval would make PSD502 be the first prescription treatment in the U.S. for premature ejaculation."

Pivotal study details

The new study, the second of two major pivotal trials, was designed to assess the clinical benefit and safety of PSD502 in men with PE.

The trial, which randomized 256 patients across 38 investigational centers in the U.S., Canada and Poland, also assessed the safety and tolerability of the therapy.

Final analyses of the 3 months data confirmed that PSD502 produced a clinically and statistically significant increase from baseline in all study primary and secondary endpoints.

The time for IELT for PSD502 group increased 4.7-fold compared to 1.5-fold in placebo (p<0.0001), resulting in a geometric mean IELT of 2.6 minutes in the PSD502 group and 0.8 minutes in the placebo group.

There were improvements in IPE scores in the PSD502 group, which recorded patient and partner feedback, compared to placebo, resulting in 5.0-, 4.6- and 2.5-point differences between PSD502 and placebo in ejaculatory control, satisfaction and distress domains, respectively (p<0.0001 between treatment comparisons).

Overall, PSD502 was well-tolerated, with no serious adverse events reported by patients or partners in the studies.

Also presented for the first time at SMSNA were two subset analyses of the European Phase III trial data showing:

-- Increased ejaculatory latency and improvements in patent-reported outcomes seen in the first month of use with PSD502 were maintained over 2 to 3 months of treatment; and

-- A significant positive correlation between mean IELT and IPE domain scores after three months of treatment, indicating that increases in IELT are associated with improvements in patient-reported outcomes.

About premature ejaculation

For years, various experts debated on the true definition of premature ejaculation. In 2008, the International Society for Sexual Medicine presented an evidence-based definition of PE as agreed upon by a consensus of the world's leading sexual health experts: a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration, and inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.

Source: Medical News Today, 20 November 2009

Topical erectile dysfunction therapy shows promise

An innovative drug-delivery system – nanoparticles encapsulating nitric oxide or prescription drugs – shows promise for topical treatment of erectile dysfunction (ED) according to a new study by scientists at Albert Einstein College of Medicine of Yeshiva University.

The new system, tested successfully on a small number of animals, could potentially prevent side effects associated with oral ED medications, if study results can be replicated in humans. That could mean safer and more effective ED therapy for millions of men with heart disease and other health problems affecting erectile function. The study is published today in the online edition of the Journal of Sexual Medicine.

Tens of millions of men worldwide have benefited from oral ED medications such as sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis). However, these medications - which belong to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors - have limitations. They can cause systemic side effects that can be serious. These side effects include headache, facial flushing, nasal congestion, upset stomach, abnormal vision as well as isolated reports of hearing and vision loss. Men who've recently suffered a heart attack or stroke or have severe heart disease should use these drugs with caution or not at all. In addition, "an estimated 30 to 50 percent of men with ED do not respond to oral use of PDE5 inhibitors," says senior author Kelvin P. Davies, Ph.D., associate professor of urology at Einstein.

The drug-delivery system, developed by Einstein scientists, consists of nanoparticles – each smaller than a grain of pollen – that can carry tiny payloads of various drugs or other medically useful substances and release them in a controlled and sustained manner.

The limited number of topical formulations of ED drugs has so far proven ineffective. This study was done to evaluate whether the Einstein nanoparticles, which have been shown to penetrate the skin, might allow the targeted delivery of compounds that treat ED and thereby avoid the drugs' systemic effects.

An effective topical therapy could be especially significant for those ED patients – particularly men with diabetes – who have reduced levels of nitric oxide (NO), the signaling molecule that dilates blood vessels responsible for erectile activity. These men, who often aren't helped by oral PDE5 inhibitor drugs, may benefit from direct application of NO or the PDE5 inhibitors.

The nanoparticles were tested on a total of 18 rats bred to have age-related ED. The rats were divided into three treatment groups. One group of seven rats received nanoparticles encapsulating NO. A second group of five rats received nanoparticles encapsulating NO plus an experimental ED drug called sialorphin (which has a mechanism of action different from PDE5 inhibitors). A third group of six received nanoparticles encapsulating NO plus tadalafil (Cialis).

Five of the seven rats treated with the NO-containing nanoparticles, and all 11 rats treated with nanoparticles encapsulating NO plus sialorphin or tadalafil showed significantly improved erectile function. None of the seven rats in a control group, which received empty nanoparticles, showed any improvement.

"Most of the animals, nearly 90 percent, showed a response to treatment with the nanoparticles," says co-author Joel M. Friedman, M.D., Ph.D., professor of physiology & biophysics and of medicine. Dr. Friedman developed the nanoparticles with his son Adam Friedman, M.D., chief resident in the division of dermatology of the department of medicine at Montefiore Medical Center, The University Hospital and Academic Medical Center for Einstein.

"The response time to the nanoparticles was very short, just a few minutes, which is basically what people want in an ED medication," adds Dr. Davies. "In both rats and humans, it can take 30 minutes to one hour for oral ED medications to take effect."

Postmortem examination of the tissues at the site of administration showed no signs of local inflammation or toxicity. "In addition, when we applied the nanoparticles at therapeutic doses, we found no indication of systemic side effects," says Dr. Friedman.

The Einstein research team will carry out safety and dosing studies in rats in the coming months. Clinical studies on humans could begin in a few years if animal studies continue to show that the nanoparticle delivery system is safe and effective. But the investigators caution that the time from a proof-of-concept trial in animals to approved use in humans may be a decade or more.


Topical Gel as an Effective New Treatment for Impotence

A gel applied to the penis may be able to help some impotent men achieve an erection, according to a study in a recent issue of the Journal of Urology. However, many users experienced an uncomfortable sensation and the potential effects of the gel on female partners is unknown.

The gel contains a hormonelike substance called alprostadil and an agent known as SEPA that helps deliver the alprostadil through the skin of the penis. Alprostadil has previously been shown to enhance erections but could only be administered with an injection. The topical treatment may be another option for impotence, or erectile dysfunction, a common, treatable condition that affects as many as 20 million American men. Current treatments for impotence include oral medications such as Viagra (sildenafil), injectable drugs, and penile implants.

In the new study, a gel containing either alprostadil or a placebo was applied to the penis in 48 impotent men. Overall, 67-75% achieved an erection after using the alprostadil gel compared with 17% applying the placebo gel, report Kevin T. McVary, MD, and colleagues. McVary is an associate professor of urology at Northwestern University Medical School in Chicago.

No serious side effects were seen, but nearly all patients experienced a warm sensation that went away within 5-20 minutes of application of either gel. Approximately 20% of the men that received the alprostadil gel described discomfort along the penis. The authors say it appears that the alprostadil is responsible for the discomfort. No evidence of serious skin reactions was seen.

In an editorial comment accompanying the study, Geoffrey N. Sklar, MD, points out that while using a gel medication for achieving erections is an attractive possibility, past experience has shown them to be largely ineffective and have many side effects.

"A central issue surrounding this route of administration is whether patients will accept discomfort when using an [erection-inducing] agent," writes Sklar, who is from the division of urology at the University of Maryland School of Medicine in Baltimore. He also suggests that gathering more information about how patients use the gel at home is important. Sklar says that gel medications may be a useful alternative when oral medications fail.

McVary says that with regard to effects the gel might have on female partners, a South American researcher found only one incidence of minor vaginal bleeding in studies of 18 women whose partners used a similar gel. "It's a different drug, but the same concept," he says.

McVary adds that the topical alprostadil gel is potentially useful for virtually all types of impotence since the study included a broad distribution of patients with different causes for their impotence.

Womb transplantation to become a reality soon

British scientists have taken a step closer to performing a womb transplant, reports reveal. At present, women whose wombs are unable to sustain a pregnancy or who are born without a womb only have surrogacy and adoption as options when starting a family. Around 15,000 women of childbearing age are thought to be in this position.Womb transplant

Now, experts at Hammersmith Hospital in London have worked out how to transplant a womb with a sufficient blood supply to support a growing baby.

Five rabbits were given donor wombs using the new technique and subsequent examinations revealed that the transplants had been successful.

Richard Smith, consultant gynaecological surgeon at Hammersmith Hospital, commented: 'I think there are certain technical issues to be ironed out but I think the crux of how to carry out a successful graft that's properly vascularised - I think we have cracked that one.'

However, Tony Rutherford, chairman of the British Fertility Society, noted that there is a 'big difference' between demonstrating the procedure in rabbits and transferring it to larger animals or humans.

Source:, 22 October 2009

More News < >


Questions & Answers

if i mastrubate within hours of my 1st ejaculation even though ejaculation dosen't occur the second time, the orifice of my penis burns like hell ...
Read answer

I got prostate cancer and Dr. told me it was probably caused by excessive testosterone levels. Can frequent masturbation cause this?

Click here if  you have a question to ask.

Pregnancy FAQs

About three days after my last period, my boyfriend and I were fooling around....
Read More

To send your question,
click here



 Rights reserved. Ramsha Instt. of Sexuality, India | This site is not a substitute for medical consultation. Use of this site is subject to the  disclaimer.