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The effect of lower dose of Ulipristal Acetate in the treatment of uterine fibroids.

Comparison of the efficacy of 2.5 mg versus 5 mg Ulipristal Acetate in the treatment of symptomatic uterine fibroids.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014984
Enrollment
60
Registered
2018-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with symptomatic Uterine fibroids

Interventions

Intervention1: Group I: Will receive Tab Ulipristal Acetate 2.5 mg od for 13 wks Control Intervention1: GROUP II: Will receive Tab Ulipristal acetate 5 mg od for 13 wks

Sponsors

Jagsonpal Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Post-menopausal women. 2. Asymptomatic women with uterine fibroids 3. Fibroid size 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.

Design outcomes

Primary

MeasureTime frame
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. 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) Timepoint: 13 wks—

Secondary

MeasureTime frame
1. To compare the reduction of dysmenorrhea with 2.5 mg vs 5 mg daily Ulipristal acetate in symptomatic uterine fibroids. 2. To assess the effect of therapy on Serum Oestradiol levels. 3. To assess the effect of 2.5 mg Ulipristal acetate on endometrial thickness. Timepoint: 13 weeks—

Countries

India

Contacts

Public ContactProfessor Nutan Agarwal

AIIMS

saroj.rajan@hotmail.com8376073567

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026