Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- FSFI (Female Sexual Function Index) questionnaire "arousal" domain
研究概览
简要总结
The objective of this study is the role of vaginal progesterone gel in the treatment of menopausal hypoactive sexual desire disorder. Half of the study participants will receive a standard dose of self applied vaginal progesterone gel and the other half will receive oral vitamin tablets.
详细描述
Steroid hormones play fundamental roles in sexual behaviour. Sexual activity is related to hormone concentrations and ovulation in women. Women's sexuality, unlike that of most mammals, is not solely defined by sexual receptivity during the short window of fertility. Women are also prone to initiate luteal-phase sex when serum levels of progesterone are highest in the menstrual cycle.As a result of ovarian hormonal cessation after menopause women may face alterations in sexual desire.
The role of progesterone supplementation in improving sexual desire in the menopausal period is investigated.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menopausal status
- •Sexually active
排除标准
- •Medical history of chronic psychiatric disease
- •Medical conditions associated with female sexual dysfunction; cardiovascular disease, uncontrolled chronic HT (hypertension) ,DM (diabetes mellitus), History of gynecologic surgery, female gynecological cancer ( breast, ovarian, uterine, cervical)
- •Medications associated with female sexual dysfunction; Antidepressants opiates, beta blockers, Antiepileptics ( gabapentin, topiramate,phenytoin) benzodiazepines
研究组 & 干预措施
Vaginal progesterone 8%
Vaginal progesterone application 8%
干预措施: Vaginal progesterone 8% (Device)
Placebo
Oral multivitamin supplement
干预措施: Vaginal progesterone 8% (Device)
结局指标
主要结局
FSFI (Female Sexual Function Index) questionnaire "arousal" domain
时间窗: 1 month
Increment
次要结局
- FSDS-R (Female Sexual Distress Scale- Revised) score(1 month)
- FSFI (Female Sexual Function Index) questionnaire "lubrication" domain(1 month)
- FSFI (Female Sexual Function Index) questionnaire all domains(1 month)