Biolipid/B2: Transdermal Testosterone Nanoemulsion in Women Libido

Sponsor

University Potiguar (Other)

Overall Status

Unknown status

CT.gov ID

NCT02445716

Collaborator

Farmacias Evidence Ltda (Other), Lemos laboratório de Análises Clínicas (Other)

Enrollment

Locations

Arms

Duration (Months)

23.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynelogical Center	Fortaleza	CE	Brazil	60115-191
2	University Potiguar	Natal	RN	Brazil	59060
3	Marco Botelho	Sao Paulo		Brazil	04023-062

Sponsors and Collaborators

University Potiguar
Farmacias Evidence Ltda
Lemos laboratório de Análises Clínicas

Investigators

Study Director: Ivaldo Silva, PhD, Federal University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Potiguar

ClinicalTrials.gov Identifier:

NCT02445716

Other Study ID Numbers:

UNIFESP/Evidence

First Posted:

May 15, 2015

Last Update Posted:

Oct 25, 2017

Last Verified:

Oct 1, 2017

Additional relevant MeSH terms:

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Study Results

No Results Posted as of Oct 25, 2017