NCT02215434

Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women

Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Potiguar · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia. Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder (HSDD) in women has been demonstrated in studies including naturally and surgically menopausal women, either alone or in combination with estrogen, with or without progestin therapy.

Detailed description

Recent studies have reported an increase in the number of satisfactory sexual events recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress. There is also evidence that testosterone therapy results in a similar improvement in sexual function in premenopausal women with loss of libido. Testosterone therapy has been associated with significantly improved well-being in studies in which the participants had low well-being at enrollment. Trials of testosterone for HSDD in women have excluded those with clinical depression, as well as those taking antidepressants. Whether testosterone will benefit women with HSDD who are taking an antidepressant is not known. The primary aim of this study was to examine the effects of transdermal testosterone therapy with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing treatment-emergent low libido. The primary study outcome was the change in the total score of the Sabbatsberg Sexual Self-rating Scale (SSS). In line with previous studies of women without depression, efficacy was measured by the change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general well-being, depression, and mood status. In this present study these factors will be analized in 12 weeks interval

Conditions

• Sex Behavior

Interventions

Type	Name	Description
DRUG	Biolipid B2 (blanked/placebo)	the intervention will be the comparison effects of both emulsions
DRUG	Testosterone, Transdermal, Behavior	Transdermal 0.5% testosterone Biolipid/B2

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-04-01
• Completion: 2014-08-01
• First posted: 2014-08-13
• Last updated: 2014-08-13

Locations

1 site across 1 country: Brazil