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One stop destination for vital information on major women's health concerns.
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Intrinsa
About Intrinsa
Intrinsa Trials
Intrinsa Female Viagra?
Why Not Viagra?
Intrinsa in the News
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Intrinsa Trials
Intrinsa patch was produced in September 2004 by the companies Procter & Gamble and Watson Pharmaceutical. To get the FDA’s approval for its Intrinsa, the manufacturer tested it on about 1,000 surgically menopausal women. Since the ovaries help produce testosterone (after surgery women suffer an instant decline in testosterone), studies have shown that 1 of 3 women who have undergone surgical menopause has low sexual desire. The test’s results and the need for a prescription treatment for FSD made the FDA give a “priority review” status on Intrinsa. The review took place on December 2, within 6 months instead of 10 months, the usually term.
Procter & Gamble presented these tests reports:
Study of 562 patients: the testosterone patch increased the frequency of “satisfying” sexual intercourse with 74% and with 56% the sexual desire for women participating on trials. The patients who used Intrinsa reported an average of 2.13 sexual intercourses in 4 weeks compared to .98 sexual activity episodes for women on the placebo.
Study of 533 women: 49% increase in sexual desire and 51% increase in the frequency of satisfying intercourses. An average of 1.53 sexual episodes in four weeks for Intrinsa’s users compared to .73 for those on placebo.
Food and Drug Administration advisory committee thumbed-down Intrinsa saying they were not pleased with the number of patients studied, the length of trials and modest benefits of the treatment. They explained longer-term safety data was needed.
Questions and answers about testosterone for women, including Intrinsa:
Q: Is there any FDA approved testosterone product that treats female sexual dysfunctions like lack of arousal or sexual desire and orgasm difficulties?
A: Not yet. But no other product has got as far as Intrinsa has in the FDA review process. Libigel, a transdermal gel, will shortly start the third phase of clinical tests. Testosterone medication is approved for men disorders only.
Q: Why is Intrinsa supposed to be submitted to further tests?
A: The main reason is the unknown long-term effects of the testosterone patch. Even though Intrinsa was tested on “surgical menopause women”, the treatment may be prescribed to patients who still have their ovaries whose response to Intrinsa is unknown yet.
Q: Another Vioxx?
A: The circumstances are similar to those of Vioxx’s approval, an anti-arthritis medicine recently withdrawn form market because researchers concluded it might increase risks of heart attacks, says Moynihan. The same as with Vioxx the media is too hasty to accept Intrinsa without proper analysis.
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Three months ago the U.S Food and Drug Administration denied Intrinsa’s approval, a medication intended to increase women’s libidos.
Clinical tests revealed that the number of “satisfying sexual intercourses” has increased form 3 to 5 a month. That wasn’t reason enough for the FDA to give approval especially after the Vioxx scandal. Additional tests need to be performed in order to prove its future users won’t be exposed to heart diseases or breast cancer.
The FDA requested years' more information although physicians have been quietly prescribing male hormone to women with low-libido condition for a long time.
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