Transdermal Testosterone Nanoemulsion in Women Libido

Menopause Clinical Trial

— Biolipid/B2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02445716
• Other study ID #: UNIFESP/Evidence
• Status: Recruiting
• Phase: Phase 2
• First received: May 7, 2015
• Last updated: October 24, 2017
• Start date: October 2015
• Est. completion date: August 2019

Study information

• Verified date: October 2017
• Source: University Potiguar
• Contact: MARCO BOTELHO
• Phone: +558586685000
• Email: marcobotelho1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

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 a-blockers and ß-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.

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Testosterone
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.
• Placebo
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.

Locations

Country	Name	City	State
Brazil	Gynelogical Center	Fortaleza	CE
Brazil	University Potiguar	Natal	RN
Brazil	Marco Botelho	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University Potiguar	Farmacias Evidence Ltda, Lemos laboratório de Análises Clínicas

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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