Transdermal Testosterone Nanoemulsion in Women Libido

Phase 2

• Conditions: Menopause
• Interventions: Drug: Placebo; Drug: Testosterone

• Registration Number: NCT02445716
• Lead Sponsor: University Potiguar

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Study Start: 2015-10
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Testosterone 500 mcg / Biolipid B2	Testosterone	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.

Primary Outcome Measures

Name	Time	Method
Change in sexual function measured by the Sexual Self-rating Scale (SSS)	Baseline and 12 weeks	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.

Trial Locations

Locations (3)

Gynelogical Center; 🇧🇷 Fortaleza, CE, Brazil

Marco Botelho; 🇧🇷 Sao Paulo, Brazil

University Potiguar; 🇧🇷 Natal, RN, Brazil