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The role of Mifepristone in the treatment of uterine fibroids.

Low dose Mifepristone in the management of uterine fibroids - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061448
Enrollment
246
Registered
2024-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: D25- Leiomyoma of uterus

Interventions

Intervention1: Mifepristone: Tab Mifepristone 25mg once daily for 3 months Control Intervention1: Tab Tranexamic acid, Tab Mefenamic acid: Tab Tranexamic acid and Tab Mefenamic acid thrice daily durin

Sponsors

Silchar Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women of reproductive age group (18-49 years) with 1. All symptomatic fibroids of different sizes and anatomical positions but less than 12 weeks size. 2. All asymptomatic fibroids of size 2.5cm or more detected on ultrasonography done for evaluation of other complaints but less than 12 weeks size. 3. Asymptomatic multiple fibroids of size less than 2.5 cm detected on sonography done for evaluation of other complaints but less than 12 weeks size.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To compare the mean PBAC scores between mifepristone and tranexamic acid, mefenamic acid in the management of uterine fibroids. - To compare the mean Numeric Pain Scale Rating scores for dysmenorrhea and intermenstrual abdominal pain between the two groups. - To compare the changes in uterine volume, fibroid dimension, and endometrial thickness between the two groups. - To compare the effect on hemoglobin levels between the two groups. Timepoint: 1 year

Secondary

MeasureTime frame
To assess the need for surgery or change of therapy between the two groups Timepoint: 1 year

Countries

India

Contacts

Public ContactPiyalee Nath

Silchar Medical College and Hospital

Drnathdas@gmail.com9435070133

Outcome results

None listed

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