Journal of South Asian Federation of Obstetrics and Gynaecology

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VOLUME 14 , ISSUE 3 ( May-June, 2022 ) > List of Articles

RESEARCH ARTICLE

Real-world Safety and Effectiveness Analysis of Norethisterone in the Management of Abnormal Uterine Bleeding

Arun Madhab Boruah, Pushpa Jaiswal, Monika Chinda, Ashok Jaiswal

Keywords : Abnormal uterine bleeding, Breakthrough bleeding, Compliance, Norethisterone, Oral progesterone, Safety

Citation Information : Boruah AM, Jaiswal P, Chinda M, Jaiswal A. Real-world Safety and Effectiveness Analysis of Norethisterone in the Management of Abnormal Uterine Bleeding. J South Asian Feder Obs Gynae 2022; 14 (3):313-316.

DOI: 10.5005/jp-journals-10006-2048

License: CC BY-NC 4.0

Published Online: 30-07-2022

Copyright Statement:  Copyright © 2022; The Author(s).


Abstract

Objective: To assess the real-world safety and effectiveness of norethisterone 10 mg-controlled release (CR) formulation in the management of abnormal uterine bleeding (AUB). Methods: This was a retrospective analysis of real-world data collected between January 2021 and March 2021 across 40 centers in India. A total of 308 women in the reproductive age-group (18–45 years) with ovulatory AUB were treated with norethisterone CR 10 mg once a day for 10 days. The data from women with a confirmed diagnosis of AUB were included in the study. The clinical records that were analyzed for the primary objectives included the time required for arresting heavy menstrual bleeding after initiating medication, the incidence of breakthrough bleeding, safety and tolerability, and the secondary objectives included the timing of withdrawal bleeding after the last tablet was taken, assessment of heaviness of bleeding, and treatment compliance. Results: The mean age [± standard deviation (SD)] was 33.8 ± 8.3 years. Out of the 308 women with AUB, the majority of women (n = 193, 63%) experienced styptic action of norethisterone 10 mg CR within 4 hours of administration of the medication, 61% of the women (n = 187) did not report any incidence of breakthrough bleeding, and 70% of the women (n = 216) reported withdrawal bleeding within 24–72 hours of administration of the last medication dose. No adverse events were reported. Heavy bleeding was noted in only 7% of the women. More than 80% of compliance with therapy was observed in 94% of women (n = 290). Conclusion: Our analyses of the retrospective data suggested that norethisterone 10 mg CR was safe and effective for the treatment of AUB in Indian women. Clinical significance: To the best of our knowledge, this is the first real-world study to show that norethisterone 10 mg CR effectively treats AUB, is safe, and is associated with a high compliance rate in Indian women of reproductive age-group (18–45 years).


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