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Study on the Effectiveness and Safety of norethisterone Acetate controlled release tablet in management of abnormal uterine bleeding

A Cross-sEctional Analysis to assess Safety and utilization of norEthisterone Acetate controlled release tablet in management of abnormal uterine bleeding in real world clinical settings of India - CEASE-1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/070268
Enrollment
3000
Registered
2024-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Torrent Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patient with more than 18 years with abnormal uterine bleeding. 2. Patients who were treated with Norethisterone acetate-controlled release tablets.

Exclusion criteria

Exclusion criteria: 1. Contraindications to any ingredient present 2. Any other factor or condition as per the discretion of treating physician

Design outcomes

Primary

MeasureTime frame
Change in bleeding pattern and endometrial thicknessTimepoint: Week 8 plus or minus 3 days—

Secondary

MeasureTime frame
Change in safety assessment for common Adverse eventsTimepoint: Week 8 plus or minus 3 days;Incidence of breakthrough bleeding in women with anemia and without anemiaTimepoint: Week 8 plus or minus 3 days;Prevalent type of Abnormal uterine bleeding based on PALM-COEIN classificationTimepoint: Week 8 plus or minus 3 days—

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Department of Obstetrics and Gynecology, Khodiyar Hospital

haneepatel6@gmail.com7948983895

Outcome results

None listed

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