Real-world Safety and Effectiveness Analysis of Norethisterone in the Management of Abnormal Uterine Bleeding
Journal of South Asian Federation of Obstetrics and
Gynaecology:
Published on July, 2022
Abnormal uterine bleeding (AUB) is defined as any type of
uterine bleeding in which the amount, duration, or frequency is excessive for
the patient, and is not attributed to any detectable systemic or uterine
pathology, or pregnancy.
The signs of AUB include heavy menstrual bleeding (above 95th
centile of the normal population), heavy and prolonged menstrual bleeding, and
intermenstrual bleeding. AUB negatively affects the emotional, physical,
sexual, and professional lives of women, thereby worsening their quality of
life.
The available treatment strategies for AUB aim to lower the
volume of bleeding and prevention of its recurrence. Some of these include
antifibrinolytic agents, nonsteroidal anti-inflammatory drugs, progesterone,
combined oral contraceptive pills, and gonadotropin-releasing hormone analogs.
The choice of the treatment strategy is based on the cause of
the disorder. Surgical treatment may be necessary in case of severe and
prolonged bleeding.
Among the oral
progesterone, Norethisterone is most commonly used in the treatment of AUB.
Norethisterone is considered an
effective and reliable treatment option for AUB among adolescents. It is used in about 38% of the AUB
patient population, owing to minimal side effects and cost-effectiveness.
Norethisterone is commonly prescribed at a dosage of 5 mg
thrice daily from day 5 to day 26 of the menstrual cycle. The dose varies
between 10 and 15 mg/day, according to the indication. This therapeutic regimen
has been shown to lower blood loss by >80%.
TAKE HOME MESSAGE:
In this study, authors determined the real-world safety and
effectiveness of the conservative management of Abnormal Uterine Bleeding (AUB)
with norethisterone formulation in a real-world scenario.
In the present retrospective analysis, norethisterone 10 mg
CR formulation was able to exert its action within 4 hours of administration in
the majority of the patients (63%), with no incidence of breakthrough bleeding
in 61% of patients. None of the participants reported any adverse event, and
their compliance with the therapy was high.
The present study in addition to other reports establishes the effectiveness of norethisterone in the management of AUB. Even in women with warfarin-induced AUB, 5 mg thrice-daily dose of norethisterone effectively and safely controls AUB.
Safety: No adverse events were reported during the
treatment period. The treatment was found to be well-tolerated. Norethisterone
is not associated with major side effects.
Effectiveness: Norethisterone is reported to be
more effective and better tolerated in the management of puberty menorrhagia as
compared to combined oral contraceptive pills. In this study, styptic action
was noted within 4 hours in the majority of the study population (63%, n= 193),
while it was noted at 5–6 hours and >6 hours among 21% (n = 64) and 16% (n =
51) of the population, respectively.
Conclusion: This retrospective data suggested that Norethisterone 10 mg CR was safe and effective for the treatment of AUB in Indian women.
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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 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: 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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