Health Condition 1: null- Women with diagnosed Leiomyoma in reproductive age group attending OPD of Gynaecology Department, COM & JNM Hospital, Kalyani and fulfilling inclusion and exclusion criteria.
Conditions
Interventions
Intervention1: Ulipristal acetate: 5 mg of ulipristal acetate per day till 12 weeks
Control Intervention1: Mifepristone: Mifepristone 25 mg per day till 12 weeks continuously
Sponsors
College of Medicine and JNM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 50 years of age group 2. A score on the pictorial blood-loss assessment chart (PBAC, in which monthly scores range from 0 to >500, with higher numbers indicating more bleeding) higher than 100 during days 1 to 8 of menstruation. 3. Fibroid-related anemia, defined as a hemoglobin level of 10.0 g per deciliter or lower. 4. Uterine size equivalent to that of a uterus at 16 weeks or less of gestation. 5. Atleast one fibroid that was 3 cm or more in diameter
Exclusion criteria
Exclusion criteria: 1. Leiomyoma more than 10 cm 2. Associated with Pregnancy. 3. Who do not agree for consent. 4. Contraindication or known allergy to ulipristal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between ulipristal versus mifepristone in managing women with leiomyoma i)Assessment of size of leiomyoma ii) Assessment of uterine bleeding.Timepoint: After 12 weeks from the initiation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life Adverse effects if any Cost effectivity Timepoint: From starting to receive drug till 12 weeks there after | — |
Countries
India
Contacts
Public ContactDr Mriganka Mouli Saha
College of Medicine and JNM Hospital, West Bengal University of Health Sciences, Kalyani
Outcome results
None listed