COMPARISON OF LOW DOSE MIFEPRISTONE WITH AN INTRAUTERINE DEVICE CONTAINING LEVONORGESTREL FOR MEDICAL MANAGEMENT OF ADENOMYOSIS

LOW DOSE MIFEPRISTONE VERSUS LEVONORGESTREL INTRAUTERINE SYSTEM (LNG-IUS) IN MEDICAL MANAGEMENT OF ADENOMYOSIS - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/054838

Enrollment

Registered

2023-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N711- Chronic inflammatory disease of uterus

Interventions

Intervention1: Low dose oral mifepristone: 10 mg oral mifepristone starting from day 1 to day 5 of menstrual cycle for 3 months Control Intervention1: LEVONORGESTREL INTRAUTERINE SYSTEM insertion: ins

Eligibility

Inclusion criteria

Inclusion criteria: Premenopausal women with symptomatic (dysmenorrhea/ dyspareunia/pelvic pain/ pelvic pressure or Heavy menstrual bleeding) and proven Adenomyosis (Ultrasound confirmed-MUSA consensus criteria)

Exclusion criteria

Exclusion criteria: 1. Uterus size >12 weeks 2. Pregnant or desiring pregnancy 3. Uterine malformation / Endometrial polyp 4. Endometrial hyperplasia (HPE) 5. Co existent fibroid uterus, undiagnosed adnexal mass 6. Severe Anemia (Hb 7. Renal or hepatic dysfunction 8. Hormonal medication (Progestogens/ GnRH/OCPâ??s) within 3 months 9. Current genital infection 10. History of neoplasms like breast cancer, uterine, ovarian etc.

Design outcomes

Primary

Measure	Time frame
1) Comparison of Mean VAS score for pain (dysmenorrhea/ dyspareunia/ pelvic pain/ pelvic pressure) from baseline and every month till 3 months and in between the low dose mifepristone and LNG- IUS groups. 2) Change in mean PBAC score for uterine bleeding from baseline and every month till 3 months and in between the low dose mifepristone and LNG- IUS groups.Timepoint: Baseline, 1 month, 2 months and 3 months	—

Measure

Time frame

1) Comparison of Mean VAS score for pain (dysmenorrhea/ dyspareunia/ pelvic pain/ pelvic pressure) from baseline and every month till 3 months and in between the low dose mifepristone and LNG- IUS groups. 2) Change in mean PBAC score for uterine bleeding from baseline and every month till 3 months and in between the low dose mifepristone and LNG- IUS groups.Timepoint: Baseline, 1 month, 2 months and 3 months

—

Secondary

Measure	Time frame
1) Change in mean uterine volume from baseline and every month till 3 months and in between the low dose mifepristone and LNG- IUS groups. 2) Comparison of side effects in both groupsTimepoint: Baseline, 1 month, 2 months and 3 months	—

Countries

India

Contacts

Public ContactCharvi Gupta

UCMS and GTB Hospital

sruthi_bhaskaran@yahoo.co.in9911582883

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026