Efficacy and safety of transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder: a systematic review and meta-analysis

The use of transdermal testosterone in menopausal women affected by hypoactive sexual desire disorder is efficient in improvement of sexual function with minimal adverse effects.

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Volume 107, Issue 2, Pages 475–482

Authors:

Chiara Achilli, M.B.B.S., Jyotsna Pundir, M.D., M.R.C.O.G., Parimalam Ramanathan, M.D., M.R.C.O.G., Luca Sabatini, M.D., M.R.C.O.G., Haitham Hamoda, M.D., M.R.C.O.G., Nick Panay, M.R.C.O.G.

Abstract:

Objective

To systematically review and summarize the existing evidence related to the efficacy and safety of transdermal T in postmenopausal women for the treatment of hypoactive sexual desire disorder (HSDD).

Design

Systematic reviews and meta-analysis.

Setting

Not applicable.

Patient(s)

Seven randomized controlled trials enrolled 3,035 participants; 1,350 women were randomized to treatment with T patch, and 1,379 women were randomized to placebo.

Intervention(s)

None.

Main Outcome Measure(s)

Primary outcome: satisfying sexual episodes. Secondary outcomes: sexual activity, orgasm, Profile of Female Sexual Function domains (desire), personal distress score, adverse events, acne, increased hair growth, facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction, total adverse events, serious adverse events, withdrawal from study, and follow-up rate.

Result(s)

The T group had significantly more satisfying sexual episodes, sexual activity, orgasms, desire, significant change in Personal Distress Scale score, androgenic adverse events, acne, and hair growth compared with the placebo group. There was no significant difference between the two groups in increase in facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction to the patch, total adverse events, serious adverse events, reasons for withdrawal from the study, and the number of women who completed the study.

Conclusion(s)

The short-term efficacy in terms of improvement of sexual function and safety of transdermal T in naturally and surgically menopausal women affected by HSDD either on or not on estrogen progestin hormone therapy is evident from this systematic review. The use of transdermal T is associated with increase in androgenic adverse events such as acne but is not associated with any serious adverse events.


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

1 Comments

Go to the profile of Bruce Carr
Bruce Carr over 3 years ago

As a previous editorial board member and a reviewer for Fertility & Sterility, I was surprised upon reading the February issue to find significant conflicts and problems in the article “Efficacy and safety of transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder: a systematic review and meta-analysis “ by Achilli, C et.al. Vol 107 No.2, p. 475.

1. The authors reviewed 1190 papers and chose 7 to evaluate for this systematic review. All 7 of these studies are funded by a single pharmaceutical company, namely Procter & Gamble, the company that makes the Intrinsa testosterone patch. In addition, all 7 of these papers have multiple authors in common which may bias the interpretation of results.
2. In the current manuscript cited above, the authors state they have nothing to disclose. In particular, the senior author Dr. Panay later appears in the manuscript as an author of two of the manuscripts reviewed. In those manuscripts, he is stated to be a consultant and lecturer for Procter & Gamble which was funding the research.
3. All 7 articles chosen to be included in this review tended to demonstrate an improvement in hypoactive sexual desire disorder, or HSDD, which appears to be possibly bias given the points made above.
4. The authors make no comments on the clinical significance of an increase in 0.93 sexual satisfying event (SSE) per month, which of course is less than 1 per month.
5. The authors only reported the results of a 300mcg patch and did not discuss the serum levels of testosterone that would result from such a dose. Dr. Shifren, who is an author on multiple of these papers reported in the New England Journal of Medicine in 2000 that these levels would be over 100ng/dl (Shifren et al NEJM 343;628, 2000). Every reproductive endocrinologist recognizes that this level would result in a significant increase in acne and unwanted hair growth, and possibly even early signs of virilization with prolonged use. In spite of the minimal benefit of <1 SSE/month, they did demonstrate an increase in androgenic events by 37%, an increase in acne by 41% and an increase in hair growth of 56% which are not emphasized.
6. This systematic review does not mention that one of the papers included (Braustein et.al. 2005) observed that a 450mcg patch showed no improvement in HSDD symptoms when compared to placebo despite higher serum levels of testosterone achieved.
7. Nowhere in this review do the authors mention that the FDA has rejected the testosterone patch produced by Procter & Gamble for use in HSDD in 2004.

As a result of the failure of the senior author to disclose his conflicts of interest, and the questionable choice of the manuscripts selected for this systematic review, readers of the journal who do not recognize these conflicts would be swayed to prescribe off-label use of Testosterone for their patients with HSDD. I feel that these facts should be pointed out to the readers of Fertility & Sterility to limit bias and allow for a better-informed decision.

Sincerely,
Bruce R. Carr, MD
Paul C. McDonald distinguished chair
Professor
Division of Reproductive Endocrinology and Infertility Program Director
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, Texas.