Health Condition 1: null- Heavy menstrual bleeding
Conditions
Interventions
Intervention1: Tablet Ormeloxifene: One tablet (60 mg) twice a week for 12 weeks followed by one tablet once a week for 4 weeks
Control Intervention1: Mala-N Tablet: One tablet once and day for 21 day
Sponsors
UCMS and GTB Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Women with menorrhagia (heavy menstrual bleeding), decided on the basis of PBAC score >100, belonging to the reproductive age group i.e. 20-40 years
Exclusion criteria
Exclusion criteria: - Patients with active bleeding needing emergency treatment. - Presence of renal or hepatic dysfunction. - Presence of abnormal coagulation profile, platelet disorders or history of thromboembolism in the past. - History of breast malignancy. -Patients with histopathological evidence of endometrial hyperplasia with atypia or those with suspicion of other malignancies such as cervix, ovary, vagina. - Endocrinoapthy or any other systemic disease causing HMB. - Pregnant patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Decrease in menstrual blood loss assessed by decrease in PBAC score. - Change in hemoglobin levels. - Histopathological change in the endometrial pattern with administration of Ormeloxifene and OCPs.Timepoint: 1st month, 2nd month, 3rd month and 4th month | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in lipid profile. - Any side effects including nausea, vomiting, headache, ovarian cyst, cervical erosion or discharge, thromboembolism, hepatic dysfunction, ectopic pregnancy. - Effect on dysmenorrhoeaTimepoint: 1st month, 2nd month, 3rd month and 4th month | — |
Countries
India
Contacts
Public ContactShalini Rajaram
UCMS and GTB Hospital
Outcome results
None listed