Medical Solutions for the 21st Century . . .
Meeting Tomorrow's Challenges Today

[Back to Newsletter Page]
[Go to Main Page]


Androgen Therapy in Women -- A Review of Clinical Trial Data

E-Newsletter No. 54

Several studies have examined the efficacy of androgen therapy in women. Preliminary results suggest efficacy in a subset of women, primarily when testosterone was administered at doses that raised serum free testosterone to the upper limits of normal. Libido, the endpoint for which the most data are available, was increased in some women. Mood and quality of life were also improved, as was bone mineral density. However, data related to these endpoints are scant.

Sex Hormones
Androgens are known to be involved in women’s arousability, response, pleasure, excitement, and intensity and ease of orgasm, as well as in initial spontaneous desire. Androgens are also involved in the active neurovascular smooth muscle response of swelling and increased lubrication, and likely affect genital sexual sensitivity.

Estrogens directly affect vulval, vaginal congestive responses and, because of their impact on mood and sleep, indirectly affect sexual interest. The link to sexual motivation and arousability has been shown in many studies of menopausal women.

Surgically Menopausal Women
Shifren et al.1 found that transdermal testosterone administered by patch to surgically menopausal women led to improvement in sexual frequency, pleasure, and mood, as compared with placebo. Efficacy was seen only with the higher dose (300 micrograms daily), which resulted in a mean free testosterone level near the upper limit of normal for women.

Laughlin et al.2 compared the testosterone levels of postmenopausal and surgically menopausal women in their 50s, 60s, 70s, or 80s with those of reproductive-age women. Interestingly, testosterone levels of postmenopausal women were lowest among women in their 50s and 60s, but were in the normal range for postmenopausal women in their 70s and 80s. The oophorectomized women in all age groups were severely androgen deficient.

Other Populations
Women with adrenal insufficiency are androgen deficient as well. Arlt et al.3 studied women with adrenal insufficiency who received either placebo or DHEA (50 milligrams daily for four months). Treatment with DHEA raised free testosterone to the low-normal range for women. Compared with placebo, DHEA significantly increased frequency of sexual thoughts, interest, and satisfaction. It also significantly improved well-being, depression, and anxiety. In subsequent studies, results were less dramatic.

Testosterone administration has been studied in women not androgen deficient. In premenopausal women with decreased libido, but not necessarily with low androgen levels, those using testosterone cream reported improvement in libido, sexual function, and quality of life, compared with the placebo group.4 In a study involving testosterone therapy in women after natural menopause, the mean level of testosterone was not that of an androgen-deficient population. The women receiving esterified estrogen and methyltestosterone reported increased sexual desire and frequency, as compared with women receiving esterified estrogen only.5 Similar results have been demonstrated with testosterone and estradiol implants.6

Bone Density
Several studies have suggested the efficacy of androgens to increase bone density. One showed correlations between free testosterone and bone density in women with hypopituitarism.7 Another found a significant increase in osteocalcin, a bone formation marker, in postmenopausal women treated with methyltestosterone plus estrogen, as compared to estrogen only.8

In one study, naturally menopausal women receiving implants of estradiol plus testosterone had a higher increase in bone density than those receiving estradiol alone. Another investigation examined bone density in surgically menopausal women receiving either oral estrogen alone or oral estrified estrogen plus methyltestosterone. An increase in bone density greater than that observed with estrogen alone was seen only in the women on the highest dose of methyltestosterone (2.5 milligrams).

Preliminary data regarding efficacy of androgens on some endpoints in a subset of women, and regarding short-term safety, are promising, but more are needed.

1. Shifren et al. N Engl J Med. 2000;343:682-8.
2. Laughlin et al. J Clin Endocrinol Metab. 2000;85:645-51.
3. Arlt et al. N Engl J Med. 1999;341:1013-20.
4. Goldstat et al. Menopause. 2003;10:390-8.
5. Lobo et al. Fertil Steril. 2003;79:1341-52.
6. Davis et al. Maturitas. 1995;21:227-36
7. Miller et al. J Clin Endocrinol Metab. 2002;87:2770-6.
8. Raisz et al. J Clin Endocrinol Metab. 1996;81:37-43.

Click here to go to the Sexual Enhancement web page

Go to Top

[Back to Newsletter Page]    
[Go to Main Page]