Transdermal Testosterone Nanoemulsion in Women Libido (Biolipid/B2)

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

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.

Study Overview

• Status: Unknown
• Conditions: Menopause
• Intervention / Treatment: Drug: Testosterone; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: MARCO BOTELHO; Phone Number: +558586685000; Email: marcobotelho1@gmail.com
• Study Contact Backup: Name: Dinalva Queiroz, PhD; Phone Number: +558588864388; Email: dinafarma@gmail.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04023-062
    • Recruiting
    • Marco Botelho
    • Contact: Ivaldo Silva, PhD; Phone Number: +551155764718; Email: ivaldosilva@gmail.com
    • Contact: Phone Number: +558586685000; Email: marcobotelho1@gmail.com
    • Sub-Investigator: Dinalva B Queiroz, PhD
    • Principal Investigator: Ivaldo Silva, PhD
  • CE
    • Fortaleza, CE, Brazil, 60115-191
      • Recruiting
      • Gynelogical Center
      • Contact: Marco A Botelho, PhD; Phone Number: ++558586685000; Email: marcobotelho1@gmail.com
      • Contact: Dinalva B Queiroz, MSc; Phone Number: ++558588864388; Email: dinafarma@gmail.com
      • Principal Investigator: Marco A Botelho, MSC, PhD
  • RN
    • Natal, RN, Brazil, 59060
      • Recruiting
      • University Potiguar
      • Contact: Dinalva B Queiroz, PhD; Phone Number: 558588864388; Email: dinafarma@gmail.com
      • Principal Investigator: Dinalva B Queiroz, MSc, PhD
      • Principal Investigator: Marco A Botelho, M.Sc., Ph.D
      • Sub-Investigator: Amalia C Rego, MS, PhD
      • Sub-Investigator: Irami A Filho, MD, PhD
      • Principal Investigator: Julia Gouveia, MD
      • Principal Investigator: Celso F Carvalho, MD
      • Sub-Investigator: Lucio M Lemos, M.Sc
      • Sub-Investigator: Giselle B Barros, MD
      • Principal Investigator: Ivaldo Silva, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Testosterone 500 mcg / Biolipid B2; 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; 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.; Other Names: Transdermal Testosterone Nanoemulsion
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Potiguar
• Collaborators: Farmacias Evidence Ltda; Lemos laboratório de Análises Clínicas

Publications and helpful links

General Publications

• 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 spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: UNIFESP/Evidence