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Comparative evaluation of two doses of Mifepristone (10 mg vs 25 mg) in the management of symptoms of uterine fibroid

Comparative evaluation of Mifepristone 10 mg vs 25 mg in the management of symptomatic uterine fibroid- A Randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021934
Enrollment
70
Registered
2019-11-08
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: D259- Leiomyoma of uterus, unspecified

Interventions

Intervention1: Tab Mifepristone 10 mg vs 25 mg: Tab Mifepristone 10 mg vs 25 mg will be administered once daily for 3 months to 70 patients 18-50 years age with symptomatic fibroid attending Gynaecolo

Sponsors

Kavita Agarwal
Lead Sponsor
Professor Dr GS Kamilya
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients 18-50 years with symptomatic fibroid Fibroid less than 15 cm Patients willing to sign informed consent and to undergo ultrasonography at 3 months Patient willing to come for follow up at 3 months and 6 months

Exclusion criteria

Exclusion criteria: Fibroid more than 15 cm Fibroid with severe anemia needing blood transfusion Fibroid with pressure symptoms Fibroid wanting immediate surgery Fibroid with pregnancy Patient not willing to come for follow up

Design outcomes

Primary

MeasureTime frame
Reduction in fibroid volume Improvement in PBAC score Timepoint: 12 weeks—

Secondary

MeasureTime frame
Improvement in Haemoglobin level Improvement in VAS score Amenorrhoea Any renal or hepatic dysfunctionTimepoint: 1 year—

Countries

India

Contacts

Public ContactKavita Agarwal

INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH KOLKATA

drgkamilya@gmail.com9433122643

Outcome results

None listed

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