se of a drug named as Ulipristal for managing the benign tumor of uterus of women who donot want operatio
Phase 4
- Conditions
- 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.
- Registration Number
- CTRI/2017/06/008942
- Lead Sponsor
- College of Medicine and JNM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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
1. Leiomyoma more than 10 cm
2. Associated with Pregnancy.
3. Who do not agree for consent.
4. Contraindication or known allergy to ulipristal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method