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Transdermal Testosterone Nanoemulsion in Women Libido (Biolipid/B2)

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ClinicalTrials.gov Identifier: NCT02445716
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
Farmacias Evidence Ltda
Lemos laboratório de Análises Clínicas
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Menopause Drug: Testosterone Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Change in sexual function measured by the Sexual Self-rating Scale (SSS) [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445716


Contacts
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Contact: MARCO BOTELHO +558586685000 marcobotelho1@gmail.com
Contact: Dinalva Queiroz, PhD +558588864388 dinafarma@gmail.com

Locations
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Brazil
Gynelogical Center Recruiting
Fortaleza, CE, Brazil, 60115-191
Contact: Marco A Botelho, PhD    ++558586685000    marcobotelho1@gmail.com   
Contact: Dinalva B Queiroz, MSc    ++558588864388    dinafarma@gmail.com   
Principal Investigator: Marco A Botelho, MSC, PhD         
University Potiguar Recruiting
Natal, RN, Brazil, 59060
Contact: Dinalva B Queiroz, PhD    558588864388    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         
Marco Botelho Recruiting
Sao Paulo, Brazil, 04023-062
Contact: Ivaldo Silva, PhD    +551155764718    ivaldosilva@gmail.com   
Contact    +558586685000    marcobotelho1@gmail.com   
Sub-Investigator: Dinalva B Queiroz, PhD         
Principal Investigator: Ivaldo Silva, PhD         
Sponsors and Collaborators
University Potiguar
Farmacias Evidence Ltda
Lemos laboratório de Análises Clínicas
Investigators
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Study Director: Ivaldo Silva, PhD Federal University of Sao Paulo

Publications of Results:
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Responsible Party: University Potiguar
ClinicalTrials.gov Identifier: NCT02445716     History of Changes
Other Study ID Numbers: UNIFESP/Evidence
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents