Transdermal Testosterone Nanoemulsion in Women Libido (Biolipid/B2)

University Potiguar

Status and phase: Unknown; Phase 2

Conditions: Menopause

Treatments: Drug: Placebo; Drug: Testosterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02445716

UNIFESP/Evidence

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 30 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Testosterone 500 mcg / Biolipid B2

Active Comparator group

Description:

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.

Treatment:

Drug: Testosterone

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo