To compare the efficacy of ormeloxifene versus oral contraceptive pills in medical management of menorrhagia due to uterine myomas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PBAC Score to assess menstrual blood loss
研究概览
简要总结
Objective: To compare efficacy of ormeloxifene (Selective Estrogen Receptor Modulator) versus combined oral contraceptive pills (novelon) in medical management of menorrhagia due to uterine myomas.
Methods: Fifty women with menorrhagia due to myomas were recruited after taking informed consent and institute’s ethical clearance. Group-I (n=25) was given ormeloxifene 60mg twice weekly & group-II (n=25) was given combined oral contraceptive pills (novelon) from day 1 to 21 of menstrual cycle for 6 months. Menstrual blood loss was assessed by pictorial blood loss assessment chart (PBAC) score, myoma related symptoms like dysmenorrhoea were assessed by Visual Analogue Scale (VAS) and myoma volume was assessed by ultrasound. Follow ups were done at 1, 3, 6 and 9 months. Haemoglobin was assessed at baseline, at 6 months and 9 months follow up.
Results: Mean baseline PBAC score reduced significantly in both groups at all follow ups. Reduction was greater with ormeloxifene. Myoma volume increased at sixth month in both the groups (p>0.05 in both groups). Seven (28%) developed ovarian cysts in group-I which disappeared after discontinuing treatment. No major adverse effect was seen in either group.
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
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients presenting with menorrhagia due to uterine myomas with intramural or subserosal myomas on ultrasound or submucosal grade 2 myomas on hysteroscopy.
排除标准
- •Patients with more than 16 weeks gravid size uterus, submucosal myomas of grade 0 or 1 on hysteroscopy, atypia on endometrial histopathology, concurrent ovarian pathology, history or currently suffering from thromboembolic disease, smokers more than 35 years age, hypertension or with history of taking hormonal treatment within 3 months of treatment initiation.
结局指标
主要结局
PBAC Score to assess menstrual blood loss
时间窗: End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment
次要结局
- Bleeding days, cycle length, VAS score for dysmenorrhoea, Myoma volume, side effect, haemoglobin(End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment, hemoglobin after 6 months of treatment)