Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- FSFI questionnaire score
研究概览
简要总结
The aim of this study is to evaluate the evolution of quality of sex life of women with POI after introduction hormone replacement therapy through the FSFI scale
详细描述
Premature ovarian failure (POI) is a pathology that affects about 1-2% of women before the age of 40. The resulting estrogen deficiency is the cause of multiple repercussions. Clinically, sexual disorders may appear in the short term, such as a decrease in libido, vaginal dryness, an increase in dyspareunia, resulting in less frequent sexual intercourse and less satisfaction with sexual life. The quality of life of these patients also appears to be reduced compared to women with normal ovarian reserve. A 2008 study showed that the sexual function of patients with POI treated with hormone replacement therapy (HRT) was normal but remained significantly lower than that of patients with normal ovarian function. However, no study has attempted to assess the evolution of the symptomatology of these patients before and after the introduction of HRT. Evidence of improvement in sexual disorders under treatment could be an additional argument to improve patient adherence and treatment compliance; as well as information for health professionals
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •positive diagnosis of POI (amenorrhea > 4 months or spaniomenorrhea > 4 months and FSH > 25 IU/L checked twice, more than 4 weeks apart)
- •absence of hormonal treatment,
- •patient's oral consent,
- •affiliated or beneficiary of health insurance
排除标准
- •contraindication to hormonal treatment (history of hormone-dependent cancer, history of ischemic arterial stroke),
- •inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
- •patient under legal protection
研究组 & 干预措施
Questionnaires
Female Sexual Function Index (FSFI) and WHO Quality of Life-BREF (WHOQOL-BREF) questionnaires at baseline and at 6 months after starting hormone replacement therapy.
干预措施: questionnaire (Other)
结局指标
主要结局
FSFI questionnaire score
时间窗: Month 6
This is a self-assessment questionnaire with 19 items. It considers 6 domains of female sexuality: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). The items are rated on a 0 or 1 to 5 point scale (low score of 0-1 to high score of 5) to determine a raw score per domain. Then, the score for each domain is multiplied by a standardised coefficient to arrive at a total score between 2 and 36. The cut-off point for differentiating between women with and without sexual problems is 26.55; a lower score reflects the existence of sexual problems.
次要结局
- FSFI score according to the aetiology and to the mode of administration of hormonal treatment(Baseline, Month 6)
- WHOQOL-BREF score(Baseline, Month 6)