Clinical trial NCT02445716: Transdermal Testosterone Nanoemulsion in Women Libido
Official title: Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Menopause
Lead sponsor: University Potiguar
Sponsor class: OTHER
Collaborators: name: Farmacias Evidence Ltda
name: Lemos laboratório de Análises Clínicas
First posted: 2015-05-15
Enrollment: 70
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in sexual function measured by the Sexual Self-rating Scale (SSS)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Gynelogical Center
state: CE
city: Natal
country: Brazil
facility: University Potiguar
state: RN
city: Sao Paulo
country: Brazil
facility: Marco Botelho
Study officials:
affiliation: Federal University of São Paulo
name: Ivaldo Silva, PhD
role: STUDY_DIRECTOR
References:
citation: Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.