A RANDOMIZED CONTROLLED INTERVENTIONAL STUDY COMPARING THE EFFECTIVENESS OF CENTCHROMAN AND NORETHISTERONE IN THE TREATMENT OF HEAVY MENSTRUAL BLEEDING
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy in terms of reduction of menstrual blood loss by PBAC(pictorial blood loss assessment) score calculation before and after treatment with Centchroman and Norethisterone.
研究概览
简要总结
Heavy menstrual bleeding is a common problem and about one-third females seek treatment for it. Although surgery is the definitive treatment, many methods of medical management are available and newer methods are still in development as it is important to prevent unnecessary surgical intervention and reduce the country’s health expenses. My study aims to determine and compare the efficacy of CENTCHROMAN ( ORMELOXIFENE) and NORETHISTERONE in the treatment of heavy menstrual bleeding. While NORETHISTERONE is widely used for this purpose, CENTCHROMAN is not used routinely for the treatment of heavy menstrual bleeding, rather it was introduced as an oral contraceptive under the family planning program of GOI since 1991. Centchroman has antiestrogenic action which helps in the suppression of endometrial hyperplasia thus can prove to be a wonder drug in the treatment of HMB with its lesser frequent dosing schedule and easy availability. It can be safely used in patients with multiple comorbidities with minimal long term side effects.
After approval of the Institutional Ethics Committee and WBUHS, 90 women between the ages of 35-55 years with biopsy proven no endometrial atypia will be enrolled for the study after informed consent. They will be allocated into 2 groups based on randomization process. Group A subjects will be started on tablet Centchroman whereas Group B subjects will be started on tablet Norethisterone for 6 months. At the start of the treatment, PBAC score, endometrial thickness by USG, Hemoglobin level and metabolic parameters of the patients will be recorded for reference.
They will be asked to come on regular follow up visits for response evaluation. The above parameters will be checked and recorded at 2 monthly, 4 monthly and 6 monthly visits. Patient satisfaction will also be noted.
After completion of the data collection, we will present the statistically significant data between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women with heavy menstrual bleeding with or without associated dysmenorrhea or chronic pelvic pain 2.All women with histologically proven endometrial hyperplasia without atypia or any other benign endometrial pathology 3.Fibroid uterus less than 12 weeks in size not distorting the endometrial cavity 4.Adenomyosis 5.All women with medical or surgical high risk factors making the subjects unsuitable for surgery.
排除标准
- •1.Active genital infection 2.Suspicion of pregnancy or malignancy 3.Submucosal fibroid distorting the endometrial cavity 4.Uterine fibroids more than 5 centimeters in size 5.Atypical endometrial hyperplasia or malignancy 6.Abnormal cervical cytology and malignancy 7.Haematological disease or abnormal coagulopathy 8.History of arterial or venous thromboembolic disorders 9.Women who want to conceive 10.Women who are not willing to give consent for the study 11.Patients with polycystic ovarian disease or history of jaundice or hepatic impairment or severe allergy or tuberculosis or renal impairment or undiagnosed vaginal bleeding or breast cancer.
结局指标
主要结局
To evaluate the efficacy in terms of reduction of menstrual blood loss by PBAC(pictorial blood loss assessment) score calculation before and after treatment with Centchroman and Norethisterone.
时间窗: PBAC score calculation before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit.
次要结局
- To compare the endometrial thickness on Ultrasonography before and after treatment with Centchroman and Norethisterone(Endometrial thickness (ET) measurement on USG before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit.)
- To check the mean Hemoglobin levels of the patients before and after treatment with Centchroman and Norethisterone(Hemoglobin level estimation before starting the treatment, at 2 monthly visit, at 4 monthly visit, at 6 monthly visit.)
- To compare the effect of Centchroman and Norethisterone on the metabolic parameters of the patient (Blood glucose levels, Liver function tests, Serum lipid profile)(Fasting blood glucose, post-prandial blood glucose, lipid profile, liver function test and glycosylated hemoglobin (HbA1C) level estimation before starting the treatment, at 2 monthly visit , at 4 monthly visit, at 6 monthly visit)
研究者
DR ANGANA DAS
ESI PGIMSR ESICMCH JOKA KOLKATA