Health Condition 1: N809- Endometriosis, unspecified
Conditions
Interventions
Intervention1: Dienogest: 2mg OD, Oral for 12 weeks(90 days)
Control Intervention1: Not applicable: Not applicable
Sponsors
Jagsonpal Pharmaceuticals Limited
Eligibility
Inclusion criteria
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
Exclusion criteria: 1.Exclusion of all patients with contraindications as per Investigators discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety The criteria for the assessment of safety and tolerability will be described in terms of adverse events and change in laboratory tests. 1.Adverse events (based on severity grades, patterns, and causality). 2.Serious adverse events (SAE; in terms of severity) 3.Clinically significant derangement in lab results 4.Clinically significant changes in vital signs, demographics, gynaecologic examination, breast examination, bleeding pattern.Timepoint: After end of treatment ie., 12 weeks (90 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Clinical response: Clinical responses will be evaluated on the basis of changes in clinical sign/symptoms, lesion reduction and reduction in pain intensity in terms of dysmenorrhea and low back pain in endometriosis and are categorized as â??cureâ?? and â??failureâ??. Timepoint: After end of treatment ie., 12 weeks (90 days) | — |
Countries
India
Contacts
Public ContactMr Kultaran Singh
Jagsonpal Pharmaceuticals Limited
Outcome results
None listed