Sex Behavior Clinical Trial
Official title:
Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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