PROSPECTIVE OBSERVATIONAL STUDY FOR SAFETY & EFFICACY OF ORMELOXIFENE & MEDROXYPROGESTERONE ACETATE IN WOMEN WITH ABNORMAL UTERINE BLEEDING
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectively
研究概览
简要总结
Abnormal uterine bleeding (AUB) is responsible for significant health problem and social embarrassment and it is one of the common reasons women seek health care. It has a significant impact on the quality of life for the women. Women with abnormal bleeding have a lower quality of life than the general female population (NPH).
AUB is a significant clinical entity. AUB and its sub group, heavy menstrual bleeding (HMB), are common conditions affecting 14–25% of women of reproductive age (Fraser et al, 2009) and may have a significant impact on their physical, social, emotional and quality of life.
In the UK, over 800,000 women seek help for AUB annually (NICE 2007).
The prevalence varies in each country. In India, the reported prevalence of AUB is around 17.9% (NPH).
Because of the morbidity associated with the surgical procedures, the Royal College of Obstetricians and Gynaecologists RCOG recommends beginning with medical management before resorting to surgical interventions, but medical management of AUB should relieve symptoms, improve quality of life and avoid the risk of surgery.
Ormiloxifene (SERM) is finding a promising role in the treatment and management of AUB. Ormeloxifene has a good patient acceptability and compliance due to its minimal side effects, low cost and simple dosage schedule than that of Medroxyprogesterone (MPA).This study will furnish the necessary information about the use of Ormiloxifene.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •All patients diagnosed with AUB attending the OPD/or for consultation in the Obstetrics and Gynaecology department of SKIMS Medical College and Hospital, Bemina, Srinagar will be enrolled during the study period.
排除标准
- •Patients with leiomyoma, adenomyosis, polyp, adnexal mass.
- •Patients with systemic disorder.
- •Patients with coagulopathy Patients with breast malignancy Patients with endometrial hyperplasia.
结局指标
主要结局
to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectively
时间窗: AFTER 4 MONTHS
次要结局
- to compare the effects of ormeloxifene and medroxyprogesterone acetate in womenn with abnormal uterine bleeding on Heamoglobon, Endometrail thickness and Pictorial blood loss assessment by Complete blood chemistry, USG and PBAC score card respectively(monthly follow up upto 4 months)