A clinical trial to compare effect of adding metformin to progesterone containing intra uterine device in patients with endometrial hyperplasia without atypia

A RANDOMISED CLINICAL TRIAL OF LEVONORGESTREL INTRA UTERINE SYSTEM WITH OR WITHOUT METFORMIN FOR TREATMENT OF ENDOMETRIAL HYPERPLASIA WITHOUT ATYPIA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/05/008548

Enrollment

Registered

2017-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Endometrial hyperplasia without atypia

Interventions

Intervention1: Emily: Levonorgestrel containing intra uterine device 52mg as 20 micrograms per day Control Intervention1: Emily and metformin: T.metformin 500 mg BD x 6 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed endometrial hyperplasia without atypia on EB. 2. Over 18 years of age. 3. USG pelvis suggesting the absence of extrauterine malignancy and lesions distorting the endometrial cavity. 4. No hypersensitivity or contraindications for Emily and metformin. 5. Ability to comply with endometrial biopsies at specified intervals 6. Negative serum or urine pregnancy test in pre-menopausal women and women 7. Understand study design, risks, and benefits and have signed informed consent

Exclusion criteria

Exclusion criteria: 1. Creatinine (Cr) > 1.5 mg/dL ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN),FBS >126mg/dl or PPBS >200mg/dl. 2. Currently receiving progestin therapy (local, topical, or systemic) for greater than 1 month. 3. Mixed histology including clear cell, serous, undifferentiated or sarcomatous elements 4. History of hypersensitivity to metformin or history of discontinuation secondary to attributed adverse effects. 5. Chronic use of cimetidine. 6. Pregnant or lactating 7. Recent ( 8. Patients with endometrial hyperplasia with atypia on EB. 9. Congenital or acquired uterine anomaly which distorts the uterine cavity 10. Immune suppressed individuals due to inceased risk of infection. 11. Contraindications to both Metformin and progestins. 12. Known diabetics on treatment. 13. Patients not willing to participate in the study.

Design outcomes

Primary

Measure	Time frame
Regression of endometrial hyperplasiaTimepoint: 6months after starting the treatment	—

Secondary

Measure	Time frame
BMITimepoint: 6months;Lipid profileTimepoint: 6months;Symptomatic reliefTimepoint: 6months	—

Countries

India

Contacts

Public ContactDr jasvinder kalra

PGIMER

jasvin201a@gmail.com9914209350

Outcome results

None listed

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