Duphaston in patients with irregular periods, apost-marketing observational study.

Phase 4

Completed

• Conditions: Health Condition 1: null- Irregular Menstrual Cycle

• Registration Number: CTRI/2012/03/002523
• Lead Sponsor: Abbott India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

• Women aged 18 years or older

• Suffering from irregular menstrual cycle for at least 3 months and for whom the physician decides to prescribe Duphaston, in accordance with locally approved package insert

• Patients willing to sign written authorization to provide data for the study

Exclusion Criteria

•Patients having known hypersensitivity to the active ingredient or excipients

•Patients having known or suspected progesterone-dependent neoplasms

•Patients having vaginal bleeding of unknown etiology

•Patients taking oral contraceptives

•Pregnant and lactating patients

•Any other condition that precludes use of Duphaston in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with history of liver disease, porphyria or depression)

•Patients not willing to sign written authorization for informed consent form

Study & Design

• Study Type: PMS
• Study Design: Not specified