Transdermal Testosterone Nanoemulsion in Women Libido (Biolipid/B2)

October 24, 2017 updated by: University Potiguar

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04023-062
        • Recruiting
        • Marco Botelho
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dinalva B Queiroz, PhD
        • Principal Investigator:
          • Ivaldo Silva, PhD
    • CE
      • Fortaleza, CE, Brazil, 60115-191
        • Recruiting
        • Gynelogical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco A Botelho, MSC, PhD
    • RN
      • Natal, RN, Brazil, 59060
        • Recruiting
        • University Potiguar
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 81 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Potiguar

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Farmacias Evidence Ltda
Lemos laboratório de Análises Clínicas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNIFESP/Evidence

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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