Quality of Life During Different Regimens of Combined Hormonal Contraceptives in Women of Reproductive Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress.
研究概览
简要总结
The aim of the present study is to investigate the psychosexual effects of combined hormonal contraception regimens, comparing them in terms of estrogen type and dosage, hormonal combination regimen and different routes of administration, in women seeking a hormonal contraception method to prevent unwanted pregnancies. In particular, the study focuses on the incidence of mood disorders and sexual dysfunctions associated with distress in the entire study population using combined hormonal contraception. It will also examine the incidence of these conditions under the influence of specific combined hormonal contraceptives, as well as whether different types of progestins and the route of administration (oral, vaginal or transdermal) may affect the occurrence of mood disorders and sexual dysfunctions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women of childbearing age (aged 18-40) who seek advice for use of combined hormonal contraception (CHC).
- •stable relationship
排除标准
- 未提供
结局指标
主要结局
Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress.
时间窗: 6 months
Evaluate the trend of the scores of the Female Sexual Function Index (FSFI) in the entire study population using combined hormonal contraception (CHC), both at baseline and after 6 months of CHC exposure; evaluate whether the FSFI scores vary significantly in relation to the type and dosage of estrogen used in hormonal contraception; evaluate the extent of female sexual distress score (FSDS) in the entire study population using CHC, both at baseline and after 6 months of CHC exposure; evaluate whether the FSDS scores vary significantly in relation to the type and dosage of estrogen used in hormonal contraception.
次要结局
- Impact of combined hormonal contraception on mood disorders(6 months)
- Impact of basal clinical variables mood disorders and sexual dysfunction in women using combined hormonal contraception(6 months)
研究者
Rossella Nappi
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia