The effect of lower dose of Ulipristal Acetate in the treatment of uterine fibroids.
Not Applicable
- Conditions
- Health Condition 1: null- Patients with symptomatic Uterine fibroids
- Registration Number
- CTRI/2018/07/014984
- Lead Sponsor
- Jagsonpal Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. At least 1 fibroid >3.0 CM in one dimension,
2. Symptomatic fibroid (PBAC >100)
3. Grade 2-7 fibroids (FIGO Classification)
Exclusion Criteria
1. Post-menopausal women.
2. Asymptomatic women with uterine fibroids
3. Fibroid size <3.0 cm (smallest dimension)
4. Grade 0-1 fibroids
5. Uterine size >20 weeks
6. Undergoing or having received medical/hormonal treatment for fibroids in the last 3 months
7. Clinical suspicion/USG features suggestive of adenomyosis.
8. History of uterine artery embolization.
9. Suspected or known case of gynecological cancer/atypical endometrial hyperplasia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine the efficacy of 2.5 mg in comparison to 5 mg of daily Ulipristal acetate in the reduction of menstrual blood loss in symptomatic uterine fibroids. <br/ ><br>2. To determine the efficacy of 2.5 mg in comparison to 5 mg daily Ulipristal acetate in the reduction in the total myoma volume (defined as the total volume of the three largest fibroids) <br/ ><br>Timepoint: 13 wks
- Secondary Outcome Measures
Name Time Method 1. To compare the reduction of dysmenorrhea with 2.5 mg vs 5 mg daily Ulipristal acetate in symptomatic uterine fibroids. <br/ ><br>2. To assess the effect of therapy on Serum Oestradiol levels. <br/ ><br>3. To assess the effect of 2.5 mg Ulipristal acetate on endometrial thickness. <br/ ><br>Timepoint: 13 weeks