Transdermal Testosterone Nanoemulsion in Women Libido

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Potiguar
• Collaborators: CURAPROX; Farmacias Evidence Ltda; INTEGRAL MÉDICA Suplementos; LAB VITRUS laboratório de Análises Clínicas; Lemos laboratório de Análises Clínicas
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.