CTRI/2022/04/041870
Active, not recruiting
Phase 4
Phase IV study to assess the safety and effectiveness ofDienogest (Visanne®) amongst Indian women withEndometriosis, in real-world clinical practice: the VISAGEStudy - VISAGE
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: N809- Endometriosis, unspecified
- Sponsor
- Bayer Pharmaceuticals Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •Contra\-indications according to the local summary of product characteristics (SPC)
Outcomes
Primary Outcomes
Not specified
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