The Testosterone Patch for Women

Summarized by Robert W. Griffith, MD
September 12, 2005

Introduction

Female sexual dysfunction, or FSD, is said to affect between 24% and 43% of women, depending on just how you ask the question (see first link, below). And although there are many causes - physical conditions, relationship difficulties, and psychological problems - scientists are looking for a 'cure' that will equal Viagra^® and its rivals.

One of the most clear-cut physical changes that cause loss of sexual desire (apart from conditions involving the genital tract) is reduction of testosterone levels following an artificial menopause. It therefore offers a good opportunity to test the effectiveness of testosterone supplementation. A recent trial of a testosterone patch has been done in women who had their ovaries for various reasons, and the results of its safety and effectiveness have been published in the Archives of Internal Medicine; we summarize them here.

What was done

Thirty to 50% of women who have their ovaries removed surgically report decreased sexual desire, and 50% have a decrease in circulating testosterone. Estrogen treatment only improves sexual desire in a proportion of them. Women were therefore selected for the study based on their replies to a series of questions about their sex life, provided they were already receiving estrogen.

A total of 447 women aged 24 to 70 were enrolled, and allocated randomly to one of 4 groups: 2 'placebo' patches, or two patches together releasing 150, 300, or 450 micrograms per day of testosterone. The patches, which were applied to the abdomen, released the testosterone in the desired amount over 3-4 days, and were replaced twice a week. The study lasted 24 weeks.

Serum testosterone and other hormone levels were measured at baseline, week 12, and week 24. Lab studies (hematology and liver function tests) were done at baseline and 24 weeks. The application sites of the patches were examined carefully at the end of the study.

The questionnaire used to assess effectiveness was the Profile of Female Sexual Function (PFSF), which measures the following 7 domains of sexual function: desire, pleasure, arousal, responsiveness, self-image, orgasm, and related concerns. All adverse effects were recorded at each visit, as well as examination of the patch site, and the possible presence of acne and hirsutism (excess body hair).

What was found

Of the 477 women enrolled, 318 completed the study. The 'drop-outs' were equally distributed among the 4 treatment groups. The time since removal of the ovaries averaged 8-10 years across the groups.

The women wearing the 300 microgram/day patches had a significantly greater increase from baseline in sexual desire, compared with those wearing the placebo patches: 67% vs. 48%. Those wearing the 150 and 450 microgram/day patches had slightly lesser increases compared with the placebo subjects.

Estimates of arousal showed similar changes; the 300 microgram/day patches produced a significant increase over the placebo, with the other two doses of testosterone showing increases, but smaller ones.

There were dose-dependent improvements in orgasm, pleasure, and decreased concerns with sex; the other two domains of sexual function were not affected by testosterone. Additional questions concerning the frequency of pleasurable sexual activity showed a significant increase in the women wearing the 300 microgram/day patches; it was 30% greater than the women receiving the placebo.

Forty-seven women withdrew from the study because of side effects; they were equally distributed across the treatment groups, including the placebo subjects. The proportion of women reporting acne, alopecia (hair loss), and hirsutism (which are known testosterone effects) was similar in all three testosterone groups, i.e. there was no obvious dose-effect.

Reactions at the patch sites were fairly common - reported by about 1 in 3 women - but they were only mild or moderate. Sixteen patients dropped out because of them. These reactions occurred equally in the placebo and testosterone groups.

There were no other reports of adverse effects, such as changes in laboratory values, during the study.

What the findings mean

Treatment with a transdermal testosterone patch that releases 300 micrograms daily, applied twice a week, is clearly effective in improving sexual desire in women who have lost their ovaries. It's not clear why the 450 microgram/day dosage was marginally less effective; it certainly resulted in higher levels of testosterone in the blood.

The authors of the study claim the patch was well tolerated. "Only" 4% of the women dropped out of the study because of skin reactions at the site, but 1 in 3 experienced some reactions, ranging from mild to moderate. This might present a problem for women with a less clear-cut cause for their lack of sexual desire. Perhaps buccal (placed in the cheek) testosterone will prove a better alternative.

If people are to take testosterone, the transdermal patch is better than oral forms as it avoids having the hormone going to the liver first, before reaching the 'target' organs; there are therefore lower risks of liver side effects. This has proved to be the case in men taking testosterone to replace age-related decline, and in patients with some forms of depression. It remains to be seen if a testosterone patch will be a useful treatment for types of FSD other than those related to ovary removal.

Source

• Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women. GD. Braunstein, DA. Sundwall, M. Katz,  et al., Arch Intern Med, 2005, vol. 165, pp. 1582--1589

Related Links
Loss of Sexual Desire in Women
HRT for Men Is Risky, Too
Sex and The Baby Boomer: Can Drug Therapy Help?
MedlinePlus: Testosterone Buccal

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