To assess how safe and effective Visanne (Dienogest) is in managing pelvic pain caused due to endometriosis
Phase 4
- Conditions
- Health Condition 1: N809- Endometriosis, unspecified
- Registration Number
- CTRI/2022/04/041870
- Lead Sponsor
- Bayer Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Female patients in India at least 18 years of age
Clinical or surgical diagnosis of endometriosis: Clinical diagnosis by suggestive symptoms
and positive finding in imaging study (Chocolate cyst)
Patients diagnosed with endometriosis associated pelvic pain who have not been previously
treated with Dienogest
Decision to initiate treatment with Dienogest was made as per investigator’s routine
treatment practice
Signed informed consent
Exclusion Criteria
Participation in an investigational program with interventions outside of routine clinical
practice
Contra-indications according to the local summary of product characteristics (SPC)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective in this study is: <br/ ><br>to assess the incidence of adverse events, in Indian Endometriosis patients on Dienogest therapy.Timepoint: 0 months, 3 months and 6 months
- Secondary Outcome Measures
Name Time Method Change in endometriosis associated pelvic pain from baseline at six months, measured by 0-10 <br/ ><br>EAPP NRS.Timepoint: 0 months, 3 months and 6 months