Effectiveness and safety of Ormiloxifene drug for irregular menstrual bleeding in women around menopausal age
Not Applicable
- Conditions
- Health Condition 1: null- Dysfunctional Uterine BleedingHealth Condition 2: N958- Other specified menopausal and perimenopausal disorders
- Registration Number
- CTRI/2018/06/014602
- Lead Sponsor
- Chirayu Parmar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Women from perimenopausal age group with menorrhagia after excluding all possible causes of abnormal uterine bleeding
2. Willing to give informed consent and agree to follow up all 3 visits
Exclusion Criteria
1. pelvic pathologies like uterine fibroids
2. suspected adenomyosis
3. malignancies of uterus/ cervix/ ovary/ vagina/ endometrial hyperplasia with atypia
4. medical disease like liver dysfunction, heart disease, migrane, stroke, renal disease, hypo / hyperthyroidism, platlet disorders or coagulopathy, previous history of thrombosis
5. pregnancy, abortion, use of IUCDs or oral contrceptives, lactating women in first six months of post natal period
6. hypersensitivity to the drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare efficacy of Ormeloxifene with combined oral contraceptive pills in treatment of Dysfunctional Uterine Bleeding by comparing pre and post treatment pictorial blood loss assessment charts and hemoglobin levelsTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method To find and compare safety of Ormeloxifene with combined Oral Contrceptive pills by noting side effects of both drugs and comparing pre and post treatment CET levelsTimepoint: 6 months