Menopause
Conditions
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.
Interventions
DRUGTestosterone
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.
DRUGPlacebo
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.
Sponsors
Farmacias Evidence Ltda
Lemos laboratório de Análises Clínicas
University Potiguar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
Primary ContactMARCO BOTELHO
Backup ContactDinalva Queiroz, PhD
Outcome results
None listed