Health Condition 1: 1- Obstetrics
Conditions
Interventions
Intervention1: Drug Dienogest: Dienogest 2mg daily for 12 weeks
Control Intervention1: Drug-Combined Oral Contraceptive Pills: Combined Oral Contraceptive Pills (0.03 mg ethinylestradiol and 0.15 mg l
Sponsors
Dr Ravisha Aggarwal
Eligibility
Inclusion criteria
Inclusion criteria: Patient having diagnosis of endometriosis established by means of documented surgical visual (laparoscopy/laparotomy) or imaging (USG/MRI) plus Presence of at least one of the symptoms dysmenorrhea, chronic pelvic pain or both or dyspareunia for more than 6 months with - Age: 18–45 years old - Endometriosis associated pelvic pain scoring more than or equal to 4 On visual analog scale (VAS) at baseline - Patients planned for medical management only for atleast 12 weeks - Women willing to participate for study
Exclusion criteria
Exclusion criteria: -Those who underwent surgery for endometriosis in between medical management. - Undiagnosed genital bleeding or other medical disorder like thyroid, bleeding disorder, liver and heart disease - Use of hormonal therapy for endometriosis within 16 weeks before enrolment including GNRH antagonists, Depot Medroxyprogesterone acetate (DMPA), progestogens, OCPs or Previously, failed treatment of endometriosis using medications included in the study - Pregnancy, lactation, and desire to conceive during treatment period. - Hypersensitivity to steroid hormones, Contraindications to COC or Dienogest use as recognized by the World Health Organization and Centers for Disease Control and Prevention -Women with acquired/congenital uterine anomaly - Patient using any systemic steroids (topical steroids allowed) over 14 days or within 3 months. - Patient has chronic pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy which could interfere with assessment of pain. - Patient having positive history of HIV, HCV and HBV or active vaginal infection. - Patient having history of major depression or other psychiatric disorder (stroke) - Previous h/o severe life threatening or other significant sensitivity for any drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in patient pain symptoms assessed by visual analog pain scale (VAS).Timepoint: Every 4 weeks till 12 weeks and after 1 month of stopping drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of adverse effect of drugs in both the groups. Timepoint: every 4 weeks till 12 weeks & after 1 month of stopping drug | — |
Countries
India
Contacts
Public ContactDR RAVISHA AGGARWAL
All india institute of medical sciences Raipur
Outcome results
None listed