Transdermal Testosterone Nanoemulsion in Women Libido

Study Overview
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Brief Summary
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This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75 years, with treatment-emergent loss of libido will be randomly allocated to the treatment with a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg of testosterone/day or an identical placebo nanoemulsion (PLA) for 12 weeks.

Detailed Description
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The aim of this study is to investigate the efficacy of transdermal testosterone nanoemulsion (TNT) as a treatment for SSRI/SNRI-emergent loss of libido. The primary outcome measures to be evaluated is the change in the Sabbatsberg Sexual Self-rating Scale (SSS) total score over 12 weeks. The 4-week frequency of Satisfactory Sexual Events (SSEs) and the Female Sexual Distress Scale-Revised (FSDS-R) will be also evaluate.

Official Title
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Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Menopause

Intervention / Treatment
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* Drug: Testosterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a body mass index between 18 and 27 kg/m2; Diminished libido; Sexual behavior complaints; No evidence of severe clinical depression; General good health based on history and physical examination. Exclusion Criteria: a past history of neurological disorder; Poor feelings for their partner; Had received pharmacotherapy for depression within 8 weeks before screening Taking medication known to interfere with normal sexual function (such as α-blockers and β-blockers); Recent psychiatric or systemic illness; Uncontrolled hypertension (blood pressure>160/95mmHg), Unstable cardiovascular disease, Genital bleeding; Use of psychoactive medications, alcohol excess consumption or any other drug abuse; Women who had under gone treatment for acne, depression, dyspareunia.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone 500 mcg / Biolipid B2<br>The arm, is part of a randomized, double-blind, placebo-controlled, parallel group trial. The arm have 35 women. It consists of a 12-week treatment phase involving three study visits and one telephone contact at week 7 of the treatment. | Drug: Testosterone<br>* It consists of a 12-week treatment with 300mcg of transdermal testosterone phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits. Participants will be submitted to a physical examination including vital signs and breast and pelvic examination. Women who met the eligibility criteria is invited to attend a baseline randomization visit. They will be randomly assigned in a 1:1 ratio to receive a transdermal testosterone nanoemulsion (0.8g per dose) delivering 300 mcg/day testosterone or an identical placebo provided by Evidence Pharmaceuticals LTDA, SP, BRAZIL. Women are asked to return all unused pumps, and treatment compliance was checked by counting weighting returned packs at their final visit.<br>* Other names: Transdermal Testosterone Nanoemulsion;|
| Placebo Comparator: Placebo<br>The arm, is part of a randomized, double-blind, placebo-controlled, parallel group trial. The arm have 35 women. It consists of a 4-week screening period plus a 12-week treatment phase involving three study visits and one telephone contact at week 7 of the treatment. Participants will be attended at the Federal University of São Paulo / Post Graduation Program in São Paulo, Brazil for their study visits. | Drug: Placebo<br>* It consists of a 12-week treatment with placebo phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual function measured by the Sexual Self-rating Scale (SSS) | The SSS is a 21-item, multiple-choice questionnaire containing seven domains (sexual interest, sexual activity, satisfaction with sexual life, experience of sexual pleasure, sexual fantasy, orgasmic capacity, and sexual relevancy). Each item has five levels scored from 0 to 4. Possible composite scores range from 0 (low sexuality) to 84 (high sexuality). It was developed to use in premenopausal and postmenopausal women . Its validity and reliability have been independently established. | Baseline and 12 weeks |