Transdermal testosterone has been evaluated over the last decade for treatment of sexual dysfunction in women. A randomized, double-blind, placebo-controlled, crossover trial evaluated the use of transdermal testosterone for surgically induced postmenopausal women with low testosterone levels and decreased sexual desire. Seventy-five women with surgically induced menopause were randomly assigned to placebo, testosterone 150 μg/day patch applied twice/week and testosterone 300 μg/day patch applied twice/week for 12 weeks in addition to oral estrogen. The placebo group was noted to have an increase in the overall BISF-W score from 52 ± 27% of normal to 72 ± 38% over 12 weeks. The investigators determined that the transdermal testosterone 300-μg/day group had significantly improved frequency of sexual activity and orgasm (p=0.03) on the BISF-W, but the 150-μg/day group did not differ significantly from the placebo group. This study indicates women with low testosterone levels have a positive physical sexual response to exogenous testosterone.
The testosterone patch was further evaluated in 447 surgically induced postmenopausal women with HSDD who were taking estrogen. HSDD was assessed using questions that compared sexual desire before and after menopause and an interest in increasing sexual activity…….. At a dose of 300 μg/day over a period of 6 months, transdermal testosterone increased the frequency by 0.58 satisfying sexual episodes/week………. The number of sexual events and orgasms on the PFSF were also increased along with desire and arousal. The sexual desire score increased 67% from baseline in the 300-μg/day group compared with 48% in the placebo group. The other active groups did not demonstrate a significant change compared with placebo. These results demonstrate a positive effect on both the psychologic and physical aspects of sex with 300 μg/day of transdermal testosterone.
Further studies of the 300-μg/day testosterone patch in surgically induced postmenopausal women with HSDD demonstrated a benefit for testosterone on increasing total satisfying sexual activity by 1.5 (p=0.001) to 2 (p=0.0003) events over 4 weeks compared with placebo, although one study did not demonstrate an increase. Significant benefit was also demonstrated for other aspects of HSDD, including improved self-image, decreased personal distress, decreased concerns, and increased responsiveness. The studies also confirmed previous significant results indicating an increase of arousal, pleasure, desire, sexual activity, and orgasm.
A phase III trial of the 300-μg/day testosterone patch was conducted in surgically induced postmenopausal women with HSDD. When asked if they found a “meaningful benefit” from the testosterone patch, 33 (52%) of 64 women who received the active patch reported “yes” compared with 21 (31%) of 68 women receiving placebo (p=0.025). The women also reported increased desire (p=0.041) and activity (p=0.011) and decreased personal distress (p<0.001 ).
A significant increase in total satisfying sexual activity at 24 weeks was seen in both trials, with INITIMATE SM 1 showing a mean increase of 2.10 sexually satisfying event episodes/4 weeks with testosterone versus 0.98 events/4 weeks with placebo (p=0.0003), whereas INTIMATE SM 2 reported 1.56 and 0.73 episodes/4 weeks in the testosterone and placebo groups, respectively (p=0.001). Skin site reactions were the most commonly reported adverse effects.
The A Study in Women with Low Sexual Desire to Evaluate the Efficacy and Safety of Oral Transdermal Testosterone Therapy in Naturally Menopausal Women Receiving Transdermal Estrogen Therapy (ADORE) study was a double-blind, parallel-group study investigating the use of a transdermal testosterone patch………….. Women assigned to testosterone patch 300 μg/day experienced a mean increase of 1.69 total sexually satisfying episodes/4-week period versus an increase of 0.53 episodes/4-week period in women who received placebo (p=0.0089). Overall, more adverse events were reported by women in the placebo group versus those in the testosterone patch 300-μg/day group. However, there were greater occurrences of both acne (4.6% vs 1.4%) and hair growth (18.5% vs 12%) in the testosterone patch 300-μg/day group versus the placebo group.
Efficacy in Premenopausal Women
Although most studies investigated the use of testosterone in postmenopausal women, questions remain about the efficacy of testosterone in premenopausal women with decreased sexual desire. A small, randomized, double-blind, placebo-controlled crossover study of topical testosterone cream was evaluated in premenopausal women with low libido. Thirty-four women were given either testosterone 1% cream 10 mg/day or a placebo to apply daily. Testosterone cream demonstrated a significant effect versus placebo on the SRS score on sexual interest, satisfaction, pleasure, fantasy, activity, and orgasm. Although this study involved a small number of participants, these results suggest that women with low sexual desire may benefit from testosterone whether before or after menopause. Additional large, randomized, controlled trials are needed to assess benefit in premenopausal women.
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