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Retrospective study using electronic medical records to evaluate usage patterns of Natural Micronized Progesterone and Dydrogesterone

A MULTI-CENTER, RETROSPECTIVE, OBSERVATIONAL, REAL-WORLD EVIDENCE STUDY USING ELECTRONIC MEDICAL RECORDS DATA TO ASSESS THE GYNECOLOGIST PREFERENCES AND DRUG UTILIZATION PATTERNS OF NATURAL MICRONIZED PROGESTERONE AND DYDROGESTERONE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/030969
Enrollment
3000
Registered
2021-02-03
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: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Control Intervention1: Not applicable as this is a retrospective study: Not applicable as this is a retrospective study

Sponsors

Sun Pharma Laboratories Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Female patients with age >10 years 2.Patient who received NMP and/or dydrogesterone

Exclusion criteria

Exclusion criteria: 1.Chronic illness like carcinoma, hepatic failure and renal failure. 2.Patients receiving chemotherapy

Design outcomes

Primary

MeasureTime frame
1. Primary Endpoint: 1.1 assessed by means of percentage of NMP formulation (capsule, SR (oral route), IM, SC, gel) prescribed for each obstetric and gynecological conditions. 1.2 ll be assessed by means of percentage prescription for each obstetric and gynecological conditions. 1.3 Drug utilization pattern will be calculatedTimepoint: 1. Baseline 2. Follow-up visit in 12 months duration from the baseline visit—

Secondary

MeasureTime frame
2. Secondary Endpoint: 2.1 Assessment of demographic and clinical characteristics of women prescribed NMP and dydrogesterone to treat obstetric and gynecological indications on the basis of the following descriptive parameters - 2.1.1 Demographic details will be evaluated for NMP and dydrogesterone 2.1.2 Clinical profile of patients will be analyzedTimepoint: 1. Baseline 2. Follow-up visit during 12 months duration from the baseline visit—

Countries

India

Contacts

Public ContactDr Sejal T Modi

Mothers Maternity and Nursing Home

shiv_kaumil@yahoo.com9327073897

Outcome results

None listed

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