Table 1.
Randomized, placebo-controlled trials investigating the use of testosterone for the treatment of sexual dysfunction in women, retrieved from databases by the search terms (and Boolean operators) testosterone use OR androgen use in women AND sexual dysfunction, and published in 1988-2012.
| Author | Study participants | Study design | Duration; follow-up | Dose | Outcome |
| 1- Myers et al. (37) | Physiologically menopausal women (n = 40) | Randomized, double-blind, placebo-controlled trial | 10 weeks | Group 1: CEEs, 0.625 mg/dayGroup 2: CEEs, 0.625 mg/day + MPA, 5 mg/dayGroup 3: CEEs, 0.625 mg/day + MT, 5 mg/dayGroup 4: placebo | Increased pleasure from masturbationNo changes in mood, behavior, or sexual arousalNote: Sexual function was normal at the outset, and there was no ERT prior to the beginning of the study |
| 2- Davis et al. (38) | Physiologically menopausal women (n = 34) | Randomized, single-blind, trial | 3 months; 2 years | Group 1: T implants, 50 mg + estradiol implants, 50 mg | Increased sexual activity, sexual satisfaction, sexual pleasure, and orgasm |
| Group 2: Estradiol implants, 50 mg only | Increased bone mineral density | ||||
| Progesterone was administered to women who had not undergone hysterectomy | |||||
| 3- Shifren et al. (45) | Surgically menopausal women with sexual dysfunction (n = 75) | Randomized, double-blind, placebo-controlled trial | 12 weeks | Group 1: CEEs, 0.625 mg/day + transdermal T patch, 150 µg/day | Increased sexual activity, sexual pleasure, orgasm, sexual fantasy, and well-being in the group of women receiving daily doses of 300 µg of T |
| Group 2: CEEs, 0.625 mg/day orally + transdermal T patch, 300 µg/day | |||||
| Group 3: CEEs, 0.625 mg/day orally + placebo | |||||
| 4- Louie K.D. (46) | Surgically menopausal women in the 31-56 year age bracket (n = 75) | Randomized, crossover, double-blind, placebo-controlled trial | 12 weeks | Group 1: Transdermal T patches, 150 µg/dayGroup 2: Transdermal T patches, 300 µg/dayGroup 3: placebo | The 300-µg/day dose was found to have significantly increased the frequency of sexual activity, sexual pleasure, and orgasm. However, it did not increase sexual desire, arousal, or receptivity |
| 5- Dobs et al. (47) | Physiologically menopausal women (n = 36) | Randomized, parallel, double-blind, trial | 16 weeks | Group 1: EEs, 1.25 mg/day (n = 18) | Increased sexual activity and pleasure in women receiving EEs (1.25 mg/day) + MT (2.5 mg/day) |
| Group 2: EEs, 1.25 mg/day + MT, 2.5 mg/day (n = 18) | Increased lean body mass, increased muscle strength, and reduced body fat in women receiving EEs (1.25 mg/day) + MT (2.5 mg/day) | ||||
| 6- Floter et al. (49) | Surgically postmenopausal women (n = 50) | Randomized, double-blind, placebo-controlled trial | 24 weeks | Group1: T undecanoate, 40 mg/day + estradiol valerate, 2 mg/dayGroup 2: Placebo + estradiol valerate, 2 mg/day | The use of estradiol valerate in combination with T undecanoate improved sexual response more significantly than did the use of estradiol valerate alone.The two groups were similar in terms of improved well-being and self-esteem. |
| 7- Goldstat et al. (39) | Premenopausal women with HSDD | Randomized, crossover, placebo-controlled trial | 12 weeks | Group1: T cream, 10 mg/dayGroup 2: Placebo | Improved sexual function, well-being, and mood |
| 8- Lobo et al. (48) | Postmenopausal women (n = 218) | Randomized, double-blind, trial | 16 weeks | Group 1: EEs, 0.625 mg/day (n = 111) | Improved libido and increased sexual frequency in women receiving EEs + MT |
| Group 2: EEs, 0.625 mg/day + MT, 1.25 mg/day (n = 107) | |||||
| 9- Buster et al. (27) | Surgically menopausal women (n = 533) | Multicenter randomized, parallel, double-blind, placebo-controlled trial | 24 weeks | Group 1: daily ERT + transdermal T patches, 300 µg/day, applied twice weeklyGroup 2: daily ERT+ placebo, applied twice weekly | Significantly increased sexual desire and frequency of sexual activityImprovement in moodLow incidence of androgenic side effects on the skin |
| 10- Simon et al. (26) | Surgically menopausal women (n = 562) | Multicenter randomized, parallel, double-blind, placebo-controlled trial | 24 weeks | Group 1: daily ERT + Transdermal T patches, 300 µg/day, applied twice weekly (n = 283)Group 2: daily ERT+ placebo, applied twice weekly (n = 279) | Slightly increased sexual desire and frequency of sexual activityImprovement in moodLow incidence of androgenic side effects on the skin |
| 11- Braunstein et al. (40) | Surgically menopausal women (n = 447) | Multicenter randomized, parallel, double-blind, placebo controlled trial | 24 weeks | Group 1: daily ERT + Transdermal T patches, 150 µg/day, applied twice weekly (n = 107)Group 2: daily ERT + Transdermal T patches, 300 µg/day, applied twice weekly (n = 110)Group 3: daily ERT + Transdermal T patches 450 µg/day, applied twice weekly (n = 111)Group 4: daily ERT + placebo, applied twice weekly (n = 119) | At a dose of 300 µg, T was well tolerated and produced increases in libido and sexual frequencyIncreased androgenic (cutaneous) side effects in the women receiving T at a dose of 450 µg |
| 12- Davis et al. (28) | Women with HSDD submitted to oophorectomy and receiving transdermal estrogen (n = 77) | Randomized, double-blind, placebo-controlled trial | 24 weeks | The women receiving transdermal estrogen started to receive 300 µg/day of T (n = 37) or placebo (n = 40) | There was an increase in sexual desire, sexual arousal, and orgasm. |
| 13- Paula et al. (41) | Postmenopausal women with sexual dysfunction (n = 85) | Randomized, crossover, double-blind, placebo-controlled trial | 4 months | Group 1: HRT + placebo (4 months)Group 2: HRT + MT, 2.5 mg/day (4 months)Group 3: HRT + placebo (2 months), followed by HRT in combination with MT, 2.5 mg/day (2 months)Group 4: HRT + MT, 2.5 mg/day (2 months), followed by discontinuation of MT and initiation of HRT + placebo (2 months) | When receiving MT, the patients in groups 2, 3, and 4 showed improvement in sexual dysfunction, principally in sexual satisfaction and desire. However, in group 3, the results were similar in the two time periods.The use of HRT in combination with MT did not change hepatic enzyme levels or increase cardiovascular risk. |
| 14- Kingsberg et al. (42) | Surgically postmenopausal women with HSDD (n = 132) | Randomized, placebo-controlled trial | 6 months | Group 1: Transdermal T patches, 300 µg/day | There was an increase in sexual satisfaction and desire. |
| Group 2: placebo | |||||
| 15- El Hage et al. (43) | Postmenopausal women submitted to hysterectomy and receiving transdermal estrogen (n = 36) | Randomized, crossover, double-blind, placebo-controlled trial | 3 months | Group 1:10 mg/day of topical T (AndroFeme® 1; Lawley Pharmaceuticals, Perth, Australia)Group 2: placebo | There was an increase in sexual desire, receptivity, and satisfaction.There was no improvement in energy or mood.There were no changes in the lipid profile. |
| 16- Penteado et al. (44) | Physiologically postmenopausal women with sexual dysfunction (n = 60) | Randomized, double-blind, placebo-controlled trial | 6 months | Group 1: CEEs, 0.625 mg/day + MPA, 2.5 mg/day + placebo (n = 29)Group 2: CEEs, 0.625 mg/day + MPA, 2.5 mg/day + MT, 2.0 mg/day (n = 31) | The women who received MT experienced increased sexual desire in comparison with those who received placebo. However, there was no difference between the two groups in terms of the ability to achieve orgasm. |
| 17- Davis et al. (56) | Postmenopausal women with HSDD and a serum level of free T < 3.8 pmol/L (n = 261) | Randomized Double-blind, placebo-controlled trial | 16 weeks | Group 1: transdermal T spray, 56 µl/dayGroup 2: transdermal T spray, 90 µl/dayGroup 3: two 90 µl applications of transdermal T spray per dayGroup 4: placebo | At a dose of 90 µl/day, transdermal T spray increased libidoThe adverse effect most often reported was hypertrichosis, which correlated with the dose and site of application |
| 18- Blümel et al. (50) | Physiologically postmenopausal women with sexual dysfunction (n = 40) | Randomized, double-blind, double-dummy trial with two parallel treatment arms | 3 months | Group1: CEEs, 0.625 mg/day+ micronized progesterone,100 mg/day + MT, 1.25 mg/day (n = 20)Group 2: placebo (n = 20) | The addition of MT to the therapeutic regimen improved the quality of life and sexuality of the postmenopausal women with sexual dysfunction. |
| 19- Panay et al. (51) | Naturally postmenopausal women (n = 272) | Randomized, multicenter, placebo-controlled trial | 6 months | Group 1: transdermal T patch, 300 µg/day | There was improvement of sexual dysfunction in the group of women receiving transdermal T. |
| Group 2: placebo | |||||
| 20- White et al. (52) | Naturally or surgically postmenopausal women with HSDD (n = 2,500, initially) | Randomized, double-blind, placebo-controlled clinical trial | The trial began in 2008, and the expected trial duration is 5 years. | Group 1: 0.22 g/day of 1% hydroalcoholic T gel (LibiGel; Biosante Pharmaceuticals, Inc., Lincolnshire, IL, USA)Group 2: placebo gel | The trial is still under way. |
CEEs: conjugated equine estrogens; DHT: dihydrotestosterone; EEs: esterified estrogens; ERT: estrogen replacement therapy; HDL: high-density lipoprotein; HRT: hormone replacement therapy; HSDD: hypoactive sexual desire disorder; LDL: low-density lipoprotein; MPA: medroxyprogesterone acetate; MT: methyltestosterone; T: testosterone.