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Sex life improves on testosterone
patch (Intrinsa) after menopause?

Information Update
from Dr. Andrew D. Atwood, Licensed Marriage and Family Therapist

This material is presented for educational and informational purposes only. No other claims are made. Always consult your health care professional for specific recommendations.


Below you will find three articles. The first is from the Associated Press, and the second is from the manufacturer, Procter & Gamble, and the third is from WebMD.

As with Viagra, be cautious about expectations. I have written elsewhere about the couples I worked with who were so excited when Viagra came out. It was as if a sustained, hard erection would solve all the problems. No way! It did for some, and it created continued problems for others.

I do have great hope, however, and you might choose to be hopeful as well.

Dr. Atwood

New patch revs up sex life after menopause
Experimental testosterone treatment helps women spice things up
By Marilynn Marchione, Associated Press – 10/20/04

PHILADELPHIA -- Menopausal women had more sex and were happier about it when using an experimental hormone patch hailed by some as a possible female equivalent of Viagra, doctors reported Tuesday.

Women on the testosterone patch had sex about four times more than they usually did in two months compared to only one additional session for women given a fake patch containing no hormone, a study found. Those who got real patches also reported more arousal, pleasure and orgasms, and had better self-images.

"We found an increase in activity, an increase in desire and a decrease in distress," said Dr. Robin Kroll, a Seattle gynecologist who reported results of the study Tuesday at a meeting of infertility specialists. The research was sponsored by Procter & Gamble Pharmaceuticals, which is developing the patch, called Intrinsa, with Watson Pharmaceuticals Inc.

It was the first big test of the patch in women who went through menopause naturally and complained of low sex drive. A previous study in women who became menopausal because of surgery found similar results, and the companies already have asked the federal Food and Drug Administration to approve its use for those women.

"The testosterone patch looks very promising. It may be the answer for what women are looking for a libido lag in menopause," said Dr. Marian Damewood, a University of Pennsylvania gynecologist who is president of the American Society for Reproductive Medicine.

As many as 30 million American women will have gone through natural menopause by 2005 and another 10 million will be menopausal because of having their ovaries removed, Procter & Gamble estimates.

Lack of interest in or pleasure from sex is a big problem for such women, partly because of the decline in testosterone. Even though men make far more of this hormone than women, females still need a certain amount of it to have healthy sex lives, experts say.
Taking testosterone pills isn't advised because it can cause excessive hair growth, liver complications and other problems. Testosterone creams that are applied to the inner thigh are an option, but they've gotten little scientific study, Damewood said.

She had no role in the patch study, which involved 549 women in Seattle, Denver, Boston, Canada and Australia, averaging 54 years old, who were upset because they didn't feel like having sex. They were assigned to get either hormone or placebo patches. All kept logs of their sexual activities and filled out standard questionnaires about their feelings.

Those on the hormone patch improved in all measures. Side effects were mild and reported by three out of four women in each group -- mostly excess facial hair and red or irritated skin from the patch, Kroll said.

"None of those patients wanted to stop taking the testosterone," she added.
The experiment was done over six months, the longest period of time the patch has been tested.

Meanwhile, a survey of 2,000 American women sponsored by Procter & Gamble and done by the Robert Wood Johnson Medical School in New Jersey found that one in three naturally menopausal women reported lackluster sex lives, but only one in 10 said it upset them.

P&G Intrinsa For Female Sexual Dysfunction To Get Cmte. Review In December

Procter & Gamble’s testosterone transdermal patch Intrinsa will be considered for the treatment of hypoactive sexual desire disorder in surgically menopausal woman receiving concomitant estrogen therapy by FDA’s Reproductive Health Drugs Advisory Committee at its Dec. 2 meeting.

P&G recently announced that the NDA (21-769) for the testosterone patch was submitted to FDA in early summer and is receiving a priority review, giving the product an estimated user fee deadline of December 2004 or January 2005.

If approved, Intrinsa would be the first treatment for female sexual dysfunction. It is estimated that about 40 mil. woman experience some form of impaired sexual function.
P&G cited Intrinsa as the company’s “next major opportunity” in the pharmaceutical market and has been priming for market entry. The company expects a July-December 2005 launch. P&G licensed Intrinsa from TheraTech, now Watson.

The Intrinsa NDA is based on the INTIMATE SM 1 and 2 trials in surgically menopausal women taking estrogen.

In the 562-patient INTIMATE SM 1 trial, women using the testosterone patch had a 74% increase in the frequency of satisfying sexual activity and a 56% increase in sexual desire from baseline. Intrinsa patients reported an average 2.13 episodes of sexual activity in four weeks compared to .98 episodes for placebo patients, P&G reported.

The 533-patient INTIMATE SM 2 trial found a 51% increase in the frequency of total satisfying sexual activity with a mean increase of 1.56 episodes every four weeks compared to .73 for placebo.

There was also a 49% increase in sexual desire (10.6 points vs. 4.3 points for placebo). Significant improvements were also seen in arousal orgasm pleasure, responsiveness, concerns, self-image and distress levels, based on the Profile of Female Sexual Function and Personal Distress Scale, P&G reported.

P&G has two ongoing Phase III trials in naturally menopausal women with hypoactive sexual desire disorder (HSDD). The company expects to present results at major medical meetings this year.

FDA Rejects Libido Drug for Women
Panel Cites Lack of Long-Term Safety Information for Intrinsa
By Todd ZwillichWebMD Medical News Reviewed By Brunilda Nazario, MDon Thursday, December 02, 2004

Dec. 2, 2004 - An FDA advisory panel refused to recommend approval of a new testosterone skin patch to treat low libido in women, saying that its manufacturer did not provide enough evidence that it is safe for long-term use.

The panel voted unanimously that Procter & Gamble, which sought to market Intrinsa, did not have sufficient data to show that prolonged exposure to testosterone is safe in women.
The company wants to market Intrinsa as a way to boost waning sexual desire in women who have had their ovaries surgically removed.

Women would wear the patch on their skin, where it delivers a steady amount of testosterone, the male sex hormone known to help stimulate sexual desire. Testosterone is also made by the ovaries in tiny amounts, which is why the company wants to limit the drug to women with removed ovaries. Women would change the patch twice a week.

Company officials estimate that as many as 900,000 women qualify as candidates for the testosterone patch. A projected 5,500 new patients could take the drug each year, but others caution that many women who are not good candidates for Intrinsa would be tempted to use the drug to improve their sex lives.

FDA scientists quickly raised doubts about Intrinsa's benefits and questioned whether the modest improvements in women's sex lives shown in studies are worth the drug's potential risks.
Women in the company's clinical trial reported that they were able to enjoy an average of five "satisfying sexual experiences" per month, up from an average of three before they started using the patch. But at the same time, women using a placebo patch reported that their number of satisfying experiences increased from three to four.

Roslyn Washington, a patient who participated in an Intrinsa study, said the drug helped restore a "healthy and satisfying" sex life and her libido, which dropped sharply after a hysterectomy 10 years ago.

"I would like to experience those feelings again," she told the panel.

Daniel Davis, MD, a reviewer with the FDA's Division of Reproductive and Urologic Drug Products, pointed out that Intrinsa only appeared to offer women one more satisfying sexual session per month than a placebo patch.

"The key issue for us is really the clinical significance of the findings," Davis said.

Concerns About Cancer, Cardiovascular Risks

Other officials cautioned that the company's one-year study did not follow patients for a long enough time to address the long-term health consequences of taking hormones. Data suggest that testosterone supplementation can raise blood pressure and alter cholesterol levels, raising concerns that the patch can increase the risk of cardiovascular disease.

"It is too small a safety database for any reasonable assessment of cardiovascular risk," said Steven Nissen, MD, a cardiologist from The Cleveland Clinic and a voting consultant to the committee.

"It is not an acceptable trade-off, and we cannot allow this to move forward until we have such data," he said.

Hormone therapy also raises lingering questions about breast cancer risk.
In the studies on the patch, the average blood level of testosterone in women using Intrinsa increased 4.5-fold by 52 weeks.

Some studies have shown higher-than-normal testosterone levels in many women with breast
cancer, but any relationship between testosterone and tumors remains essentially unknown.
Three women using Intrinsa and one using the placebo were diagnosed with breast cancer during clinical trials, though too little data exist to determine if the cancers were connected to the drug, said FDA scientist Lisa M. Soule, MD.

"The current safety database is unable to answer many questions about the long-term safety," Soule told the panel.

Fears of the risks of long-term hormone medication have risen since the release in 2002 of a study known as the Women's Health Initiative (WHI). That study was halted after revealing that a popular hormone replacement therapy containing estrogen and progestin and taken by millions of menopausal women increased the risk of heart disease and breast cancer.

Procter & Gamble sought Intrinsa's approval while the FDA is under heavy scrutiny over its handling of several drug safety issues including Merck's recent withdrawal of the pain drug Vioxx and new warnings of suicide risk associated with antidepressants in children.

Procter & Gamble officials unveiled a planned program using insurance claims records to closely monitor the patch's safety once it is on the market. The plan includes five years of tracking by an independent expert panel that would report directly to the FDA on its findings.

"P&G Pharmaceuticals will monitor the long-term safety of Instrinsa. We are committed to making this happen," said Michael Steinbuch, PhD, the scientist in charge of post-market safety.

Several witnesses warned of Intrinsa's potential for being prescribed to women who are on a quest for sexual stimulators but aren't good candidates for the drug. Some media coverage has already billed the drug as a women's version of erectile dysfunction drugs marketed for men with waning sex lives.

"It may well be promoted with a giggle and wink as the female Viagra. Not so," said Leonnore Tiefer, PhD, a New York psychologist and sex therapist who testified in front of the panel.
Company officials stressed that they intend the drug only for the narrow group of women defined by the drug's proposed indication.

SOURCES: Daniel Davis, MD, reviewer, Division of Reproductive and Urologic Drug Products, FDA. Lisa M. Soule, MD, Division of Reproductive and Urologic Drug Products, FDA. Michael Steinbuch, PhD, director of pharmacovigilance and epidemiology, Procter & Gamble. Leonnore Tiefer, PhD, psychologist and sex therapist, New York. Steven Nissen, MD, cardiologist, The Cleveland Clinic. Pharmalive.

© 2004 WebMD Inc. All rights reserved.

Best wishes,
Dr. Atwood

Hopeful Solutions for Your Sexless Marriage is the BIG, 173 page eBook written by Dr. Atwood. The companion volume is You Can Save Your Marriage. You can find both at www.HopefulSolutions.net. Dr. Andrew D. Atwood, LMFT. 534 Fountain St. NE, Grand Rapids, MI 49503 - Voice 616.456.1178 - Email DrAtwood@HopefulSolutions.net. ©2002-2004 Save Your Marriage, PLC. All rights reserved.

Disclaimer: The material presented on these pages if for your information only. It is not a substitute for professional medical advice. It may not represent your true individual medical situation. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified health care provider in person. Please consult your health care provider in person if you have any questions or concerns. Always use common sense and research your own personal situation thoroughly.

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