Health Condition 1: N719- Inflammatory disease of uterus, unspecified
Conditions
Interventions
Intervention1: Etonogestrel (ETN) Subdermal Implant (SDI): ETN-SDI is found to be very effective long acting reversible
contraceptive method and offers an additional benefit of reduction in pelvic pai
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients clinically diagnosed with endometriosis (Complains of non-cyclical chronic pelvic pain and/or dysmenorrhea > 6 months) with either a) Radiological diagnosis of endometriosis based on TVS and MRI. b) Surgically and histologically confirmed diagnosis of endometriosis.
Exclusion criteria
Exclusion criteria: 1. Not willing to participate in the study 2. Any known allergy to progesterone 3. Uterine fibroids 4. Endometrial polyps 5. Cardiovascular, hepatic, renal impairment, or any other contraindications and special warnings for treatment with Etonogestrel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of ETN-SDI in reducing endometriosis associated non-cyclic pain and dysmenorrhea as compared to LNG-IUS.Timepoint: VAS SCORE ASSESSMENT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the acceptability of ETN-SDI in participants (adolescent and reproductive age women) 2. Health related quality of life at baseline and monthly up to 6 months 3. Vaginal bleeding pattern baseline and monthly up to 6 months 4. To study the effect of ETN-SDI and LNG IUS on BMD at baseline, 12 and 24 months 5. To study the effect of ETN-SDI and LNG IUS on biomarkers like CA-125 (Baseline and after 6 months) 6. To study the effect of ETN-SDI and LNG IUS on hormones (E2, FSH, LH)- Baseline and after 6 months 7. Withdrawal rate 8.Overall degree of satisfaction (Likert scale) 9. Any adverse events associatedTimepoint: 1. Health related quality of life: Endometriosis Health profile-30 questionnaire 2. Vaginal bleeding pattern: Assessed using menstrual calendar 3. Effect on BMD: Measuring BMD at spine, femoral head and distal radius of the non- dominant forearm using dual-energy X-ray absorptiometry. 4. CA-125 measurement 5. Withdrawal rate (Months of continuation will be recorded) 6. Overall degree of satisfaction (Likert scale) 7. E2, FSH, LH measurements 8. Any adverse events associated | — |
Countries
India
Contacts
Public ContactDr Neha Varun
All India Institute of Medical Sciences, Delhi
Outcome results
None listed