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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Sex Behavior

Intervention / Treatment
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* Drug: Biolipid B2 (blanked/placebo)
* Drug: Testosterone, Transdermal, Behavior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a body mass index between 18 and 35 kg/m2 diminished libido complaints no evidence of severe clinical depression participants in good health based on history and physical examination. Exclusion Criteria: a past history of neurological disorder recent psychiatric or systemic illness use of psychoactive medications alcohol excess consumption or any other drug abuse. women who had under gone treatment for cardiovascular disease, genital bleeding, acne, depression, dyspareunia or those who had received oral androgen therapy in the previous 3 months were excluded in addition women taking medications known to interfere with sex steroid metabolism were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Biolipid B2 (blanked/placebo)<br>The study is a single-center, single-blind, placebo-controlled, parallel group trial. It consists of a 4-week screening period plus a 12-week treatment phase. At the screening visit, all participants underwent a physical examination including vital signs and breast and pelvic examination. They were randomly assigned in a 1:1 ratio to receive a transdermal vehicle biolipid B2 (identical placebo) provided by Evidence Pharmaceuticals Inc, SP,BRAZIL. The testosterone and placebo emulsion were alcohol-free matrixes that were applied topically to the forearm daily for the period of 12 weeks. | Drug: Biolipid B2 (blanked/placebo)<br>* the intervention will be the comparison effects of both emulsions<br>* Other names: Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil;Drug: Testosterone, Transdermal, Behavior<br>* Transdermal 0.5% testosterone Biolipid/B2<br>* Other names: Transdermal testosterone Biolipid/B2;|
| Active Comparator: Testosterone, Transdermal, Behavior<br>Testosterone 0.5%, daily, 3 months | Drug: Biolipid B2 (blanked/placebo)<br>* the intervention will be the comparison effects of both emulsions<br>* Other names: Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil;Drug: Testosterone, Transdermal, Behavior<br>* Transdermal 0.5% testosterone Biolipid/B2<br>* Other names: Transdermal testosterone Biolipid/B2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfactory sexual events | Recent studies have reported an increase in the number of satisfactory sexual events (SSEs) recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total testosterone and SHBG levels at screening and after 12 weeks of treatment. | Total testosterone and SHBG levels were determined at screening and week 12. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Libido; Sexual Dysfunction; testosterone