Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Change in sexual function measured by the Sexual Self-rating Scale (SSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Testosterone 500 mcg / Biolipid B2
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.
干预措施: Testosterone (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in sexual function measured by the Sexual Self-rating Scale (SSS)
时间窗: 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.
次要结局
未报告次要终点