Health Condition 1: null- Irregular Menstrual Cycle
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Krishna Maternity Hospital