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

Phase 2

Completed

• Conditions: Health Condition 1: null- Endometrial hyperplasia without atypia

• Registration Number: CTRI/2017/05/008548
• Lead Sponsor: Postgraduate institute of medical education and research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 51

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 < 2 years after the onset of menopause

7.Understand study design, risks, and benefits and have signed informed consent

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 ( < 4 weeks) active, documented, cervical infection or active PID.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regression of endometrial hyperplasiaTimepoint: 6months after starting the treatment

Secondary Outcome Measures

Name	Time	Method
BMITimepoint: 6months;Lipid profileTimepoint: 6months;Symptomatic reliefTimepoint: 6months