Health Condition 1: null- Dysfunctional Uterine Bleeding Health Condition 2: N958- Other specified menopausal and perimenopausal disorders
Conditions
Interventions
Intervention1: Ormeloxifene: 60 mg Ormeloxifene twice a week for 12 weeks followed by once a week for 12 weeks
Control Intervention1: Oral Contraceptive Pills: Low Dose Oral Contraceptive Pills contai
Sponsors
Chirayu Parmar
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Chirayu Parmar
Baroda Medical College
Outcome results
None listed