A study between mifepristone and norethisterone for uterine fibroid management.

Comparative study of Mifepristone and Norethisterone for symptomatic relief of heavy menstrual bleeding in uterine myoma- A randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095302

Enrollment

Registered

2025-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: N938- Other specified abnormal uterine and vaginal bleeding

Interventions

Intervention1: Group A (Mifepristone) : Group A (Mifepristone): Tab. Mifepristone 25 mg orally once daily for 3 months. Control Intervention1: Group B (Norethisterone): Group B (Norethisterone): Tab.

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with uterine myoma more than 2cm on ultrasound. PBAC score more than or equal to 100(heavy menstrual bleeding)

Exclusion criteria

Exclusion criteria: Coagulation disorders. History of thromboembolic events (DVT, PE) Malignancy of reproductive tract. Known allergy to mifepristone/norethisterone. Concurrent hormonal therapy use. Known liver or renal disorder.

Design outcomes

Primary

Measure	Time frame
Mean reduction in PBAC scoreTimepoint: 3 months	—

Secondary

Measure	Time frame
Mean improvement in hemoglobin levels Timepoint: 3 months;Mean reduction in myoma volumeTimepoint: 3 months	—

Countries

India

Contacts

Public ContactOishi Debnath

Lady Hardinge Medical College

debnathoishi11@gmail.com9933991146

Outcome results

None listed

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