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ulipristal acetate in the management of fibroid uterus

evaluation of efficacy and safety of Ulipristal actate in the management of symptomatic uterine fibroids

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024325
Enrollment
50
Registered
2020-03-27
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: N858- Other specified noninflammatory disorders of uterus

Interventions

Intervention1: ULIPRISTAL ACETATE: ulipristal acetate tablets of 5mg once daily for 12 weeks starting from the 5th day of menstrual cycle with an 8-week treatment-free follow up. Maximum number of two

Sponsors

sangam jha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Reproductive and premenopausal women (18-50 years age group) • Symptomatic fibroid (heavy menstrual bleed, pain abdomen, pressure symptoms and infertility) • Uterine fibroids >=1 in number and size of >= 2cm and

Exclusion criteria

Exclusion criteria: • Patients refusing medical management • Patients with HMB due to causes other than fibroids • Patients with clinical jaundice or deranged liver function tests

Design outcomes

Primary

MeasureTime frame
Decrease in the total number and size of fibroidTimepoint: At the end of two courses of 12 weeks ulipristal acetate—

Secondary

MeasureTime frame
Improvement in symptoms of heavy menstrual bleed and dysmenorrheaTimepoint: At the end of two courses of 12 weeks ulipristal acetate—

Countries

India

Contacts

Public Contactsangam jha

AIIMS PATNA

sangam.jha78@gmail.com9827388001

Outcome results

None listed

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