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

Duphaston in cycle regularization: A post-marketing, prospective, multicenter, observational study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/03/002523
Enrollment
1000
Registered
2012-03-27
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: null- Irregular Menstrual Cycle

Interventions

Intervention1: DUPHASTON: Route - Oral. Dosage - As per investigator discretion. Duration of treatment - duration of treatment with Duphaston can be anything between 1 to 6 cycles, or longer, based

Sponsors

Abbott India Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
â?¢ To determine percentage of patients reporting a regular cycle (defined as cycle duration between 21 to 35 days, inclusive) at the end of treatment period.Timepoint: Three Months

Secondary

MeasureTime frame
â?¢ To describe evolution of amount of menstrual bleeding from baseline to end of treatment, by assessing average number of pads changed per day at baseline and at the end of treatment.Timepoint: Three Months

Countries

India

Contacts

Public ContactTrivedi Nilesh Chandrakant

Krishna Maternity Hospital

drnilyami@yahoo.co.in07922890273

Outcome results

None listed

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