Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02215434
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
Sponsor:
University Potiguar
Organization:
Study Overview
Official Title:
Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESTOSTERONE
Brief 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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: