A study to evaluate the safety and efficacy of Dienogest in patients suffering from endometriosis
Phase 4
- Conditions
- Health Condition 1: N809- Endometriosis, unspecified
- Registration Number
- CTRI/2020/10/028556
- Lead Sponsor
- Jagsonpal Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients with a confirmed diagnosis of Endometriosis based on laparoscopy or
imaging
2.Patients who receive a prescription of DIENOGEST according to the
indication stated in the local approved SmPC.
3.Written informed consent signed by the patient or legally acceptable
representative(s) in line with applicable re.gulation of country.
4.Planned treatment in line with the Summary of Product Characteristics, i.e.
exclusion of all patients with contraindications.
Exclusion Criteria
1.Exclusion of all patients with contraindications as per Investigators discretion
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety <br/ ><br>The criteria for the assessment of safety and tolerability will be described in terms <br/ ><br>of adverse events and change in laboratory tests. <br/ ><br>1.Adverse events (based on severity grades, patterns, and causality). <br/ ><br>2.Serious adverse events (SAE; in terms of severity) <br/ ><br>3.Clinically significant derangement in lab results <br/ ><br>4.Clinically significant changes in vital signs, demographics, gynaecologic <br/ ><br>examination, breast examination, bleeding pattern.Timepoint: After end of treatment ie., 12 weeks (90 days)
- Secondary Outcome Measures
Name Time Method Efficacy <br/ ><br>Clinical response: Clinical responses will be evaluated on the basis of changes in <br/ ><br>clinical sign/symptoms, lesion reduction and reduction in pain intensity in terms of <br/ ><br>dysmenorrhea and low back pain in endometriosis and are categorized as â??cureâ?? <br/ ><br>and â??failureâ??. <br/ ><br>Timepoint: After end of treatment ie., 12 weeks (90 days)