Study Design and Duration |
Patient Population |
Intervention |
Results |
Oral therapy |
Randomized, double-blind, placebo-controlled, crossover; 10 mo33 |
102 women with menopausal symptoms |
Estrogen 0.25 mg/day vs methyltestosterone 5 mg vs estrogen-methyltestosterone vs placebo |
42% of women taking testosterone alone had subjective report of increased libido; 23.5% of women taking combination therapy reported increased libido (no statistical analysis reported) |
Observational; 3 mo–2.5 yrs34 |
61 menopausal or postmenopausal women and 9 men |
Low-dose androgen-estrogen combination (methyltestosterone 2 mg + ethinyl estradiol 0.002 mg) |
15 (25%) of 61 women reported increased libido vs baseline |
Randomized, double-blind, placebo-controlled; 10 wks35 |
40 naturally postmenopausal women |
CEE 0.625 mg vs CEE + medroxyprogesterone acetate 5 mg vs CEE + methyltestosterone 5 mg vs placebo daily |
No significant differences among groups for sexual behaviors or arousal; ↑ pleasure from masturbation for testosterone-estrogen group vs all other groups (p<0.046) |
Randomized, double-blind, parallel group; 8 wks36 |
20 postmenopausal women taking estrogen for 12 mo |
Esterified estrogens 1.25 mg/day vs estrogens + methyltestosterone 2.5 mg/day |
No significant difference in vaginal blood flow velocity between groups |
Randomized, double-blind, placebo-controllled, crossover37 |
8 healthy premenopausal Caucasian women |
Testosterone undecanoate 0.5 mg sublingually × 1 dose vs placebo |
↑ genital responsiveness (vaginal pulse amplitude, p=0.04), ↑ genital sensations (subjective reports, p=0.02), and ↑ sexual lust over 4.5 hrs (p=0.01) for testosterone vs placebo |
Randomized, double-blind, placebo-controlled crossover38 |
10 postmenopausal women without sexual dysfunction |
Methyltestosterone 5 mg vs placebo × 1 dose over 2 visits |
↑ genital sexual response (vaginal pulse amplitude) at 4.5 hrs after dose for methyltestosterone vs placebo (p=0.03); no significant difference for subjective sexual response between groups |
Randomized, double-blind, parallel-group; 8 wks39 |
20 postmenopausal women dissatisfied with estrogen therapy |
Esterified estrogens 1.25 mg/day vs esterified estrogens + methyltestosterone 2.5 mg/day |
↑ sexual sensation and desire for testosterone group vs estrogen alone (p<0.01); no significant difference in frequency of sexual activity between groups |
Randomized, double-blind, parallel group; 16 wks40 |
37 postmenopausal women taking estrogen therapy for at least 3 mo |
Estrogen 1.25 mg/day vs estrogen 1.25 mg + methyltestosterone 2.5 mg/day |
↑ sexual function, pleasure, or orgasm (p=0.041), ↑ sexual interest (p=0.014) for testosterone group vs estrogen alone |
Randomized, double-blind, placebo-controlled, crossover; 24 wks41 |
50 postmenopausal women after hysterectomy and oophorectomy |
Testosterone undecanoate 40 mg + estradiol 2 mg/day vs placebo + estradiol 2 mg/day |
↑ enjoyment of sex (p<0.05), ↑ satisfying sex with frequent sexual activity (p<0.05), ↑ interest in sex (p<0.05), and ↑ McCoy sex scale questionnaire score (p<0.05) for testosterone group vs estrogen group |
Randomized, double-blind, parallel-group; 16 wks42 |
218 postmenopausal women with HSDD taking estrogen |
Esterified estrogens 0.625 mg/day vs estrogens + methyltestosterone 1.25 mg |
↑ sexual interest or desire (p=0.05), ↑ frequency of desire/interest (p<0.01), ↑ responsiveness (p=0.002), and ↑ Sexual Interest Questionnaire total score (p<0.01) for testosterone group vs estrogen alone |
Injectable therapy |
Observational, pilot; 6 mo43 |
17 postmenopausal women with decreased libido while taking CEE 1.25 mg/day |
Estradiol 40 mg + testosterone 100-mg implant subcutaneously |
↑ libido (p<0.01), ↑ enjoyment (p<0.01), ↓ tiredness (p<0.01), and ↑ concentration (p<0.05) vs baseline |
Randomized, single-blind; 24 wks44 |
20 postmenopausal women with decreased libido while taking oral estrogen replacement |
Estradiol 40-mg implant vs estradiol + testosterone 50-mg implant subcutaneously |
↑ libido (p<0.01) and ↑ enjoyment (p<0.01) for testosterone group vs estrogen alone |
Randomized, prospective, crossover; 3 mo45 |
53 women with surgically induced menopause |
Estrogen 10 mg vs testosterone 200 mg vs estrogen 8.5 mg + testosterone 150 mg vs placebo intramuscularly once/mo |
↑ intensity of sexual desire (p<0.001), ↑ intensity of arousal (p<0.001), and ↑ frequency of sexual fantasies (p<0.001) for both testosterone groups vs estrogen or placebo |
Observational cohort; 28 days46 |
44 postmenopausal women who underwent hysterectomy or oophorectomy 4 yrs earlier |
Estrogen 8.5 mg + testosterone 150 mg vs estrogen 10 mg intramuscularly once/mo vs placebo |
↑ sexual desire (p<0.01), ↑ sexual arousal (p<0.01), ↑ no. of fantasies (p<0.01), ↑ coitus and orgasm (p<0.01) for testosterone group vs estrogen alone or placebo |
Randomized, single-blind; 2 yrs47 |
33 postmenopausal women |
Estradiol 50-mg implant subcutaneously vs estradiol + testosterone 50-mg implant subcutaneously every 3 mo |
↑ orgasm (p<0.035), ↑ sexual satisfaction (p<0.03), ↑ pleasure (p<0.01), and ↑ sexual activity (p<0.03) for testosterone group vs estrogen alone |
Transdermal therapy |
Randomized, double-blind, placebo-controlled, crossover; 12 wks48 |
75 women with hysterectomy and oophorectomy, impaired sexual dysfunction, testosterone levels<30 ng/dl, and taking estrogen 0.625 mg/day for 2 mo |
Testosterone patch 150 g/day or 300 μg/day twice/wk vs placebo |
↑ frequency of sexual activity (p=0.03) and ↑ frequency of pleasure-orgasm (p=0.03) for testosterone 300 g/day vs placebo |
Randomized, double-blind, parallel-group, placebo-controlled; 24 wks49 |
447 surgically menopausal women with HSDD while taking oral estrogen |
Testosterone patch 150, 300, or 450 g/day twice/wk vs placebo |
↑ frequency of sexual activity by 79% (p=0.049), ↑ no. of sexual events (p=0.01), ↑ orgasms (p=0.02), ↑ desire (p=0.05), and ↑ arousal (p=0.04) for testosterone 300 g/day vs placebo |
Randomized, double-blind, placebo-controlled; 24 wks50 |
533 women with HSDD after hysterectomy and oophorectomy |
Testosterone patch 300 g/day twice/wk (applied to abdomen) vs placebo |
↑ frequency of total satisfying sexual activity by 1.56 episodes/4 wks (p=0.001), ↑ self-image (p=0.03), ↓ personal distress (p=0.009), ↑ sexual activity (p=0.013), ↑ orgasms (p<0.001), ↑ arousal (p=0.001), ↑ pleasure (p<0.001), ↓ concerns (p=0.001), and ↑ responsiveness (p<0.001) for testosterone vs placebo |
Randomized, double-blind, placebo-controlled; 24 wks51 |
562 surgically menopausal women with HSDD |
Testosterone patch 300 g/day twice/wk vs placebo |
↑ frequency of total satisfying sexual activity by 2.1 episodes/4 wks (p=0.0003), ↑ sexual desire (p=0.0006), ↓ distress (p=0.0006), ↑ no. of orgasms (p=0.0002), and ↑ sexual activity (p=0.0036) for testosterone vs placebo |
Randomized, double-blind, placebo-controlled; 24 wks52 |
77 oophorectomized women with HSDD |
Testosterone patch 300 μg/day (applied to abdomen) twice/wk vs placebo |
↑ sexual desire 66% (p=0.02), ↑ arousal (p=0.02), ↓ personal distress (p=0.003), ↑ orgasm (p=0.05), no significant difference for frequency of satisfying sexual activity, ↑ responsiveness (p=0.005), ↑ sexual self-image (p=0.04), and ↓ sexual concerns (p=0.003) for testosterone vs placebo |
Randomized, double-blind, placebo-controlled, phase III substudy; 24 wks53 |
132 surgically menopausal women with HSDD |
Testosterone patch 300 g/day applied twice/wk vs placebo |
52% of women using testosterone patch reported a meaningful benefit compared with 31% of women using placebo patch (p=0.025); ↑ sexual activity (p=0.011), ↑ desire (p=0.041), and ↓ distress (p<0.001) for testosterone vs placebo |
Randomized, double-blind, placebo-controlled, phase III; 32 wks (each trial)54 |
562 surgically menopausal women (INTIMATE SM 1) and 532 surgically menopausal women (INTIMATE SM 2), all with HSDD |
Testosterone patch 300 g/day twice/wk vs placebo |
INTIMATE SM 1: mean ↑ from baseline of 2.10 sexually satisfying episodes/4 wks in women receiving testosterone vs 0.98 episodes/4 wks in those receiving placebo (95% CI 0.5–1.73, p=0.0003); INTIMATE SM 2: mean ↑ from baseline of 1.56 episodes/4 wks in women receiving testosterone vs 0.73 episodes/4 wks in those receiving placebo (p=0.001,); both studies: ↑ desire at 24 wks for testosterone vs placebo (p=0.0006) |
Randomized, double-blind, placebo-controlled; 52 wks55 |
814 postmenopausal women with HSDD not receiving estrogen |
Testosterone patch 150 g or 300 g/day (applied to abdomen) twice/wk vs placebo |
↑ 4-wk frequency of satisfying sexual episodes in those receiving 300 g vs placebo (↑ 2.1 vs 0.7 episodes, p<0.001), which was not seen in the 150-g group (1.2 episodes, p=0.11); ↑ desire in 300-g group (p<0.001) and 150-g group (p=0.04) vs placebo; ↓ distress in 300-g group (p<0.001) and 150-g group (p=0.04) vs placebo |
Randomized, double-blind, placebo-controlled; 24 wks56 |
272 naturally menopausal women |
Testosterone patch 300 g/day twice/wk (applied to abdomen) vs placebo |
↑ total satisfying sexual episodes for those receiving testosterone 300 g/day vs placebo (p=0.0089); ↑ sexual desire (p=0.0007) and ↓ personal distress (p=0.0024) for testosterone 300 μg/day vs placebo |
Randomized, double-blind, placebo-controlled crossover; 3 mo57 |
36 surgically menopausal women with low sexual desire using transdermal estrogen |
Testosterone cream 10 mg/day topically (applied to forearm) vs placebo |
↑ Brief Index of Sexual Functioning for Women score by 9 points (p<0.001), ↑ sexual thoughts or desire (p=0.024), ↑ frequency of sex (p=0.039), and ↑ receptivity or initiation of sex (p<0.001) for testosterone vs placebo |
Randomized, double-blind, placebo-controlled phase III; 12 wks58 |
216 postmenopausal women with moderate-to-severe vaginal atrophy |
Dehydroepiandrosterone 0.25%, 0.5%, or 1% intravaginal ovule/day vs placebo |
↑ Menopause Specific Quality of Life Sexual Desire score at 8–12 wks for 1% group vs placebo (p<0.01); no significant difference in sensation or ↑ orgasm for 1% group vs placebo at 12 wks (p<0.05); ↓ vaginal dryness for all doses vs placebo at 8–12 wks (p<0.005); ↓ avoiding intimacy for 1% group vs placebo at 8–12 wks (p<0.05); and ↑ arousal-lubrication for 1% group vs placebo at 8–12 wks (p<0.03) |
Randomized, double-blind, crossover; 2 mo59 |
10 premenopausal women with HSDD |
Testosterone gel 50 mg (applied to abdomen or shoulders) 4–8 hrs before intercourse up to twice/wk with shower after intercourse vs placebo |
↑ arousal for testosterone vs placebo (p=0.03); results not significant for desire, lubrication, orgasm, and satisfaction for testosterone vs placebo |
Randomized, double-blind, placebo-controlled, crossover; 12 wks60 |
34 premenopausal women with low libido |
Testosterone 1% cream 10 mg/day (applied topically to thigh) vs placebo |
↑ Sabbatsberg Sexual Self Rating Scale (p=0.001), ↑ sexual interest (p=0.001), ↑ sexual activity (p=0.006), ↑ satisfaction of sexual life (p=0.004), ↑ sexual pleasure (p=0.004), ↑ sexual fantasy (p<0.001), and ↑ orgasm (p=0.005) for testosterone vs placebo |
Randomized, double-blind, placebo-controlled dose-ranging; 16 wks61 |
261 premenopausal women with decreased sexual satisfaction |
Testosterone spray 1 × 56-μl dose, 1 × 90-μl dose, or 2 × 90-μl doses vs placebo |
↑ mean number of satisfactory sexual events over 16 wks significantly greater for 90-μl dose vs placebo (p=0.044) |
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