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TO COMPARE THE EFFECTS OF LEVENORGESTREL RELEASING INTRAUTERINE SYSTEM AND DEPOT MEDROXYPROGESTERONE ACETATE IN TREATMENT OF HEAVY MENSTRUAL BLEEDING

A COMPARATIVE STUDY ON THE EFFECTS OF LEVENORGESTREL RELEASING INTRAUTERINE SYSTEM AND DEPOT MEDROXYPROGESTERONE ACETATE IN TREATMENT OF HEAVY MENSTRUAL BLEEDING - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057366
Enrollment
60
Registered
2023-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: N850- Endometrial hyperplasia Health Condition 2: N921- Excessive and frequent menstruation with irregular cycle Health Condition 3: N945- Secondary dysmenorrhea

Interventions

Intervention1: Levenorgestrel releasing intrauterine system: Releases 20 microgram levenorgestrel per day to control heavy menstrual bleeding. It is inserted only once in 5years in the intrauterine ca

Sponsors

ESI MEDICAL COLLEGE, JOKA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All women having heavy menstrual bleeding with or without associated dysmenorrhea or chronic pelvic pain All women with histologically proven endometrial hyperplasia without atypia or any other benign endometrial pathology Fibroid uterus Adenomyosis Medical or surgical high-risk factors making the subjects unsuitable for surgery Age group between 30-50 years

Exclusion criteria

Exclusion criteria: Active genital infection Suspicion of pregnancy, malignancy Uterine fibroids or submucosal fibroid distorting the endometrial cavity Atypical endometrial hyperplasia or malignancy Abnormal cervical cytology and malignancy Haematological disease, abnormal coagulopathy Liver disease, uncontrolled diabetes mellitus H/o arterial or venous thromboembolic disorders Women who are willing to conceive.

Design outcomes

Primary

MeasureTime frame
Decrease in the menstrual bleeding Increase of Hb level at 3 monthly interval Decrease in the endometrial thicknessTimepoint: after 4 weeks of administration and then every 3 monthly till 1year

Secondary

MeasureTime frame
Decrease of pain Satisfaction level Discontinuation of therapy and its cause Treatment failure Management after treatment failureTimepoint: after 1 week of administration, then after 4 weeks, every 3 monthly for 1 year

Countries

India

Contacts

Public ContactSUMANA SARKAR

ESIPGIMSR AND ESIC MEDICAL COLLEGE JOKA

drshreyasibid@gmail.com9830525422

Outcome results

None listed

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