To Evaluate the Efficacy of Cabergoline as compared to GnRH Agonists in women with Endometriosis: A Prospective Open label Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Reduction in VAS score of pain more than 50% in these women.
研究概览
简要总结
This study is a prospective randomized, open label, parallel group, trial comparing the efficacy of Cabergoline 0.5mg tablet twice weekly and Leuprolide 3.75mg subcutaneous injections monthly for 4 months in 50 patients with endometriosis that will be conducted in Department of Obstetrics and Gynaecology, AIIMS. The primary outcome measures will be reduction in pain Visual Analog Score(VAS) by >50% and change in the pre and post treatment level of serum Vascular Endothelial Growth Factor(VEGF) after 4 months of treatment. The secondary outcomes will be reduction in size of endometrioma, changes in ovarian blood flow, change in pulse wave velocity of brachial artery and change in the serum levels of CA-125 and Prolactin after 4 months of treatment.
Dosages: Cabergoline 0.5 mg twice weekly orally
Leuprolide 3.75 mg monthly subcutaneously
Duration of treatment: 4 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women with a clinical diagnosis with endometriosis by previous laproscopy or USG.
- •2.Presence of ovarian endometrioma not more than 6cm in diameter.
- •3.Women do not want to conceive for next 6 months.
排除标准
- •1.Patients with history of any hormonal treatment including contraceptives over past 3 months.
- •2.Body mass index (BMI) more than 30 kg/m
- •3.Patients with known history of allergy to one of the study medications.
- •4.Confirmed pregnancy.
- •5.H/o smoking, tobacco chewing.
- •6.Presence of hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease or any inflammatory disease.
结局指标
主要结局
1.Reduction in VAS score of pain more than 50% in these women.
时间窗: 4 months
2.Change in pre and post treatment levels of serum highly purified CRP(hpCRP),TNF-alpha and VEGF.
时间窗: 4 months
次要结局
- Changes in Resistive Index (RI) and Pulsatility Index(PI) of ovarian blood flow.(4 months)
- Reduction in size of Endometrioma as calculated by USG(more than 25% reduction will be taken as effective)(4 months)
- Changes in Pulse wave velocity of brachial artery(4 months)
- Changes in the level of serum CA-125 and serum prolactin(4 months)