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Commentary on Androgen Deficiency in Women and the FDA Advisory Board’S Recent Decision to Request More Safety Data

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Commentary on Androgen Deficiency in Women and the FDA Advisory Board’S Recent Decision to Request More Safety Data International Journal of Impotence Research (2005) 17, 375–376 & 2005 Nature Publishing Group All rights reserved 0955-9930/05 $30.00 www.nature.com/ijir Perspectives Commentary on androgen deficiency in women and the FDA advisory board’s recent decision to request more safety data A Guay1* 1Center for Sexual Function, Lahey Clinic, Peabody, MA, USA Editor’s note: The FDA’s decision regarding Intrinsa has potential widespread implications for the medical treatment of female sexual dysfunction (FSD). Dr Andre Guay is a world-renowned authority on the topic of female sexuality and FSD. Accompanying Dr Spark’s perspective in issue 2, this perspective will shed important light on the topic and offer insight into the past, present and future of FSD. International Journal of Impotence Research (2005) 17, 375–376. doi:10.1038/sj.ijir.3901332 Published online 12 May 2005 In early December 2004, the FDA Advisory Board and projected use were strictly for replacement in held a conference to review the clinical trial data menopausal women whose levels went below a on Procter & Gamble’s testosterone patch, called normal therapeutic range as compared to young Intrinsat. The FDA reviewed two trials in surgically women, a formula that is widespread when dealing menopausal women and submitted for efficacy. with normal male levels of testosterone. Two of the trials in naturally menopausal women, Women produce androgens from two organs, the submitted for safety, were of 6 and 12 months, with ovaries and the adrenal glands, as opposed to the extension data to 18 months. The FDA voted vast majority of testosterone produced in the male unanimously to request the gathering more long- testicle. At menopause, or a few years thereafter, the term safety data. The full FDA regulatory committee ovarian production of androgens ceases. This loss of did not vote on the issue as Proctor & Gamble half of a woman’s androgen production is coupled withdrew the drug from further consideration. with the decreased production of adrenal androgens This is an unfortunate decision for various that commences in the 20’s, with the result that reasons. The most important result of a favorable shortly after menopause women may have lost 75% decision would go much further than just approving of their androgen production. another treatment modality. We have lost the The symptoms of androgen deficiency in women opportunity of having a country and a regulatory are similar to those seen in men, decreased libido, agency validate the concept and diagnosis of decreased energy and decreased sense of well being. androgen deficiency in women. This could have Women often present with decreased lubrication, facilitated requests for research funding in this area, even when adequately estrogenized. Muscle and made androgen deficiency a valid topic for function and bone metabolism may also be seen in evaluation, even though many doctors have been both sexes. Decreased arousability is also seen in treating it off-label for decades. More research is women with androgen deficiency. Decreased sexual needed to define more precisely the significance of a desire is certainly a hallmark symptom, and can also low testosterone level in women, not unlike the be a prominent symptom in depression and other debate regarding male patients. condition such as acute and chronic illness, medi- Some people with negative feelings toward the cation, relationship problems, etc. It is the duty of idea of women receiving testosterone predicted its the evaluating health-care professional to rule out widespread use and even abuse. The clinical trials these conditions, realizing, of course, that many women may have more than one cause of decreased libido. *Correspondence: A Guay, MD, FACP, FACE, Center for The request for more safety data is never to be Sexual Function, Lahey Clinic, One Essex Center Drive, faulted. You can never have enough safety data. Of Peabody, MA 1960, USA. course, there really are no long-term safety data in E-mail: [email protected] many areas concerning men on testosterone replace- Received 3 January 2005; accepted 3 January 2005 ment, the exception being prostate abnormalities. Symptoms of androgen deficiency in women A Guay 376 In the six months exposure with the 2200 women stroke, showed a decrease in breast cancer, and no in the Phase III studies, one would expect that increase in cardiac disease. any problems with hirsuitism, acne or hirsuitism Apart from the issues raised above, which are would be seen during this time frame. The fear valid concerns and should be debated, there may that testosterone would be aromatized to estrogen have been some bad timing and political pressures is more paranoia than reality. The amount of brought to bear on the decision not to accept the testosterone converted to estrone or estradiol has current data on the female testosterone patch. been shown to be low, making any risk of breast Congress has been quite concerned with the with- cancer extremely unlikely. Even the Million Women drawal of Vioxxt and other drugs from the market Study in the UK on the effect of hormone replace- because of deaths felt to be related to the use of these ment therapy on breast cancer had serious design drugs. Questions have been raised about the in- flaws. The study showed a slight risk of breast ability to detect defects in medicines studied under cancer, but there are several problems with the FDA-accepted protocols resulting in serious mor- design of the study, including a significant recruit- bidity and mortality. An obvious conclusion is that ment bias. more and longer-term safety data may be required The HERS and WHI studies that showed a slight before drugs are released into the marketplace. increase in vascular disease with conjugated estro- Unfortunately, the fact that testosterone is a natural gen and synthetic progesterone were severely compound and not a drug foreign to the body does flawed. The HERS study found an increase in not seem to enter into this equation. In this context, vascular events in women who had already had the request for more safety data cannot be unex- had vascular events. The WHI study found in- pected. Also, testosterone has been given to post- creased vascular events in a general population of menopausal women for decades, albeit off-label, menopausal women, but the mean duration of with no serious safety problems being discovered. menopause of the women entering the study was The problem is that there are no long-term safety 12 y, almost predisposing the study to failure as studies. Long-term data are also wanting in men, estrogen therapy is felt to be preventative and not and a recent study has shown safety data in men on reparative. Very recent studies in younger women testosterone therapy up to 42 months, where the have suggested a protective effect of hormone majority completed only 36 months. replacement therapy. There are those who also feel Hopefully, the further data required will be that a strong synthetic progestin, like medroxy- reasonable and we will be able to look forward to progesterone acetate, may nullify any good effect treat postmenopausal women who have androgen of estrogen on the vascular endothelium. The WHI deficiency with a reliable product. This will help to study using estrogen alone in hysterectomized open up a new era of treatment in female sexual women, although showing a very small increase in dysfunction. International Journal of Impotence Research.
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