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To compare the efficacy of depot leuprolide and oral progesterone in management of heavy menstrual bleeding due to fibroid

preoperative management of heavy menstrual bleeding in leiomyoma with depot leuprolide vs oral norethisterone- A Randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037049
Enrollment
60
Registered
2021-10-01
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: N939- Abnormal uterine and vaginal bleeding, unspecified

Interventions

Intervention1: INJECTION LEUPROLIDE: INJECTION for 2 cycles Control Intervention1: TABLET NORETHISTERONE: ORALLY for 2 cycles

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PRESENTING TO GYNAE OPD OF LHMC AND SSKH WITH CYCLICAL HEAVY MENSTRUAL BLEEDING AND DIAGNOSED WITH LEIOMYOMA ON USG

Exclusion criteria

Exclusion criteria: 1 KNOWN CASE OF UNCONTROLLED HYPOTHYROIDISM 2 WOMEN WITH ANTICOAGULANTS 3 WOMEN WITH HEMOGLOBIN LESS THAN 5 GM PER DL WITH HEMODYNAMIC INSTABILITY 4 UNCONTROLLED DIABETES 5 UNCONTROLLED HYPERTENSION 6 MIGRAINE 7 HISTORY OF THROMBOEMBOLIC EPISODES

Design outcomes

Primary

MeasureTime frame
1 Proportion of women with PBAC score of 50 or less in depot leuprolide and oral norethisterone group after first and second cycle Timepoint: First and second of treatment—

Secondary

MeasureTime frame
1.Proportion of women with improvement in hemoglobin level of 1 gm% at 1 month and 2gm% at 2 month in group A& B 2.Proportion of women with improvement in myoma volume of 15% at 1 month and 25% at 2 month group A & B Timepoint: First and second cycle of treatment—

Countries

India

Contacts

Public ContactGeetanjali

Lady Hardinge Medical College

drratnabiswaspaul@yahoo.co.in9971372695

Outcome results

None listed

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