Retrospective study using electronic medical records to evaluate usage patterns of Natural Micronized Progesterone and Dydrogesterone
Not Applicable
Completed
- Conditions
- Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2021/02/030969
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3572
Inclusion Criteria
1.Female patients with age >10 years
2.Patient who received NMP and/or dydrogesterone
Exclusion Criteria
1.Chronic illness like carcinoma, hepatic failure and renal failure.
2.Patients receiving chemotherapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Primary Endpoint: <br/ ><br>1.1 <br/ ><br>assessed by means of percentage of NMP formulation (capsule, SR <br/ ><br>(oral route), IM, SC, gel) prescribed for each obstetric and <br/ ><br>gynecological conditions. <br/ ><br>1.2 ll be assessed <br/ ><br>by means of percentage prescription for each obstetric and <br/ ><br>gynecological conditions. <br/ ><br>1.3 Drug utilization pattern will be calculatedTimepoint: 1. Baseline <br/ ><br>2. Follow-up visit in 12 months duration from the baseline visit
- Secondary Outcome Measures
Name Time Method 2. Secondary Endpoint: <br/ ><br>2.1 Assessment of demographic and clinical characteristics of <br/ ><br>women prescribed NMP and dydrogesterone to treat obstetric and <br/ ><br>gynecological indications on the basis of the following descriptive <br/ ><br>parameters - <br/ ><br>2.1.1 Demographic details will be evaluated for NMP and <br/ ><br>dydrogesterone <br/ ><br>2.1.2 Clinical profile of patients will be analyzedTimepoint: 1. Baseline <br/ ><br>2. Follow-up visit during 12 months duration from the baseline visit