Drug treatment with mifepristone (formanagement of uterine fibroids to avoid surgery

Role of mifepristone (RU 486) in management of uterine leiomyoma

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002470

Enrollment

150

Registered

2012-03-02

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- Women having symptomatic leiomyoma uterus or women with ultrasound diagnosed leiomyoma of more than 5cm in size.

Interventions

Intervention1: Mifepristone (RU 486): Mifepristone was given as 25 mg /day in group 1 and as 10mg/day in group 2, starting initially from day 2-3 of periods. Duration of treatment was 3 months. Interv

Eligibility

Inclusion criteria

Inclusion criteria: Women having symptomatic leiomyoma uterus or leiomyoma of more than 5cm in size

Exclusion criteria

Exclusion criteria: Uterine size more than 20 weeks , myoma size more than 15 cm on ultrasound, pregnancy, lactation, abnormal liver function, abnormal unexplained vaginal bleeding and use of steroid anticoagulant â?? HRT, GnRH within 3 months.

Design outcomes

Primary

Measure	Time frame
Percentage reduction in symptoms related to fibroidTimepoint: After 3 months treatment and then 3 months after stopping treatment.	—

Secondary

Measure	Time frame
Percentage reduction in fibroid size on ultrasound, Hb% estimation, Estradiol levels Timepoint: After 3 months treatment, then 3 months after stopping treatment	—

Countries

India

Contacts

Public ContactAlka Kriplani

All India Institute of Medical Sciences, New Delhi, India

kriplanialka@gmail.com91-11-26594933

Outcome results

None listed

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