Comparative efficacy of combined oral contraceptives and ormeloxifene in the management of abnormal uterine bleeding
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in amount and duration of menstrual blood loss by assessing pattern of periods through PBAC (Pictorial blood assessment charts) score.
研究概览
简要总结
Eligible participants will be recruited after fulfilment of inclusion criteria at the time of first visit to GMCH-32.
Patients will be divided into the two treatment groups by use of computer- generated random numbers. Group A will be given a combined oral contraceptive pill containing ethinyl estradiol 30 mcg and levonorgestrel 150mcg on days 1-21 for 4 months. Group B patients will be given ormeloxifene 60 mg twice a week for 2 months followed by 60mg once a week for the next 2 months. In order to conceal allocation, the computer- generated numbers will be delivered to the patients in opaque, sealed envelopes. It will be an open label trial. Detailed history, baseline general examination and complete gynaecological examination will be done for all patients recruited into the study. Assessment of blood loss will be done using PBAC (pictorial blood loss assessment chart) score. Severity of dysmenorrhoea will be graded according to Numerical Pain Rating Scale (NRS). Patient satisfaction with treatment will be assessed using Treatment Satisfaction Questionnaire for medication (TSQM).
An ultrasonographic confirmation of presence of fibroid or adenomyosis will be done. Bilateral adnexa will be assessed before beginning the therapy for any cysts in the ovaries or adnexal mass. Blood samples will be collected for investigations including complete hemogram with peripheral blood film, coagulation profile, baseline liver and renal function tests.
Follow up will be done at 2 months and 4 months after starting treatment. Note will be made of any side effects observed by the patient such as gastric upset, headache, weight gain, mastalgia etc
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
- •Women presenting to Gynaecological OPD with Abnormal Uterine Bleeding related to structural causes of the uterus, uterine fibroids and adenomyosis.
排除标准
- •Women with bulky fibroids presenting with pressure symptoms who are not fit for medical management.
- •Submucosal fibroid type 0 and type
- •Endometrial polyp, endometrial hyperplasia or malignancy.
- •Complex adnexal mass.
- •Abnormal renal or hepatic function tests.
- •Coagulopathy.
- •History of breast or genital malignancy.
- •Thromboembolic disease.
- •Diabetes, hypertension, migraine or epilepsy.
结局指标
主要结局
Change in amount and duration of menstrual blood loss by assessing pattern of periods through PBAC (Pictorial blood assessment charts) score.
时间窗: At the end of 2 months and 4 months after the start of treatment.
次要结局
- 1. Change in pain score after medication based on NRS (Numerical pain rating score).(2. Patient satisfaction with treatment using TSQM (Treatment satisfaction questionnaire for medication).)
研究者
Dr Harmanpreet Kaur
Government Medical College and Hospital, Sector 32, Chandigarh