Transdermal Testosterone Nanoemulsion in Women Libido

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.

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.

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.