A randomized trial to compare the effectiveness of Levonorgestrel-releasing intrauterine device and Gonadotropin-releasing hormone agonist in the treatment of adenomyosis in women nearing menopause (40-52 years)

Comparison of Levonorgestrel releasing intrauterine device vs. Gonadotropin-releasing hormone agonist (GnRH) in the treatment of adenomyosis in perimenopausal women: An open-label randomized trial - RCT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047926

Enrollment

Registered

2022-12-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: N924- Excessive bleeding in the premenopausal period

Interventions

Intervention1: Arm 1 - Levonorgestrel releasing intrauterine device: Patients in Arm 1 will be called in the post-menstrual phase for the LNG - IUD insertion (Mirena) and will be contacted after their

Eligibility

Inclusion criteria

Inclusion criteria: Women in the perimenopausal (40-52 years) age group presenting to us with complaints of heavy menstrual bleeding (with PBAC score more than or equal to 100) with or without pain and were diagnosed with adenomyosis on USG.

Exclusion criteria

Exclusion criteria: -Patient allergic to GnRH agonist (leuprolide). -Patient on anticoagulants of any type like heparin, LMWH, warfarin, etc. -Patients who are diagnosed with any other gynecological pathology other than adenomyosis.

Design outcomes

Primary

Measure	Time frame
To study the effectiveness of Levonorgestrel-releasing intrauterine device and Gonadotropin- releasing hormone agonist in reducing heavy menstrual bleeding as assessed by Pictorial blood loss assessment chart score in patients with adenomyosis in the perimenopausal age group.Timepoint: Pictorial blood loss assessment chart score will be calculated at the first visit, at 3 months and 6 months follow-up.	—

Measure

Time frame

To study the effectiveness of Levonorgestrel-releasing intrauterine device and Gonadotropin- releasing hormone agonist in reducing heavy menstrual bleeding as assessed by Pictorial blood loss assessment chart score in patients with adenomyosis in the perimenopausal age group.Timepoint: Pictorial blood loss assessment chart score will be calculated at the first visit, at 3 months and 6 months follow-up.

—

Secondary

Measure	Time frame
To compare the Levonorgestrel-releasing intrauterine device and Gonadotropin-releasing hormone agonist in - Pain reduction assessed by Visual analog scale score. - In uterine volume reduction.Timepoint: Visual analog score and uterine volume will be assessed at the first visit, at 3 months and 6 months follow-up.	—

Countries

India

Contacts

Public ContactDr Priyanka Garg

All India Institute of Medical Sciences, Bathinda

priyanka.garg.u@gmail.com6280628137

Outcome results

None listed

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