Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sexual health (self reported questionnaires)
研究概览
简要总结
The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires. Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.
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
- 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
- •Clinical, echographical or surgical diagnosis of endometriosis
排除标准
- •Comorbidity
- •Psychiatric diseases
- •Refusal or inability to sign informed consent
研究组 & 干预措施
Balanced estroprogestins
Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days.
干预措施: Estroprogestinic therapy (Etinil-estradiol/levonorgestre) (Drug)
GnRHa
Women assigned to this arm will assume Leuprorelin acetate (3,75 mg/2ml), one intramuscular administration every 28 days. After 45 days of treatment, therapy will be implemented with Tibolone 5 mg, one tablet daily orally, and Calcium carbonate/colecalciferol (500 mg/400 UI), one tablet daily orally. This therapy will be prosecuted for the remaining 135 days of treatment.
干预措施: Gonadotropin-releasing hormone agonist (Leuprorelin acetate) (Drug)
GnRHa
Women assigned to this arm will assume Leuprorelin acetate (3,75 mg/2ml), one intramuscular administration every 28 days. After 45 days of treatment, therapy will be implemented with Tibolone 5 mg, one tablet daily orally, and Calcium carbonate/colecalciferol (500 mg/400 UI), one tablet daily orally. This therapy will be prosecuted for the remaining 135 days of treatment.
干预措施: Add back therapy 1 (tibolone) (Drug)
GnRHa
Women assigned to this arm will assume Leuprorelin acetate (3,75 mg/2ml), one intramuscular administration every 28 days. After 45 days of treatment, therapy will be implemented with Tibolone 5 mg, one tablet daily orally, and Calcium carbonate/colecalciferol (500 mg/400 UI), one tablet daily orally. This therapy will be prosecuted for the remaining 135 days of treatment.
干预措施: Add back therapy 2 (calcium carbonate/colecalciferol) (Drug)
结局指标
主要结局
Sexual health (self reported questionnaires)
时间窗: 180 days
This outcome will be evaluated through self reported questionnaires
Quality of life (self reported questionnaires)
时间窗: 180 days
This outcome will be evaluated through self reported questionnaires
Psychological impact (self reported questionnaires)
时间窗: 180 days
This outcome will be evaluated through self reported questionnaires
次要结局
未报告次要终点
研究者
Stefano Angioni
MD,PhD
University of Cagliari