International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
Clinical outcomes among Centchroman users across six medical college hospitals in India.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Radhika A G, Suneja Amita, Gupta Rashmi, Dorairajan Gowri, Aggarwal Pratima, Ashok Venkatesh, Suri Vanita, Singla Rimpi, Nanda Smiti, Chauhan Meenakshi, Rani Vandana, Arora Nalini, Chaudhary Rachna, Gupta Abhilasha, Malhotra Rajeev Kumar, Singh Shalini
Аннотация
OBJECTIVE: To evaluated the effectiveness, safety, acceptability, and continuation rates of ormiloxifene (Centchroman) which is licensed for contraception only in India.
METHODS: The prospective observational analytical study was conducted across six centers in India from June 2019 to May 2023. A mixed cohort of 3139 women who opted for Centchroman out of 36 625 eligible women were followed up for 24 months.
RESULTS: Mean age of participants was 26 ± 4.4 years. Menstrual abnormalities were the most common side effect, at an average of 1.03-1.17 events per woman. Discontinuation rates were highest within the first 3 months (40.9%) due to menstrual disturbances, notably reduced menstrual flow (60% at 18 months), amenorrhea, heavy or irregular bleeding, and spotting. Life table analysis revealed continuation rates of 78.0%, 47.3%, and 32.2% at 6 weeks, 6 months, and 24 months, respectively. Overall satisfaction from 6 weeks to 12 months after initiation was 75.2%. Failure rate ranged from 0.7%-2.1%. Mean endometrial thickness remained stable throughout the study period (6.54 ± 2.49 to 7.80 ± 1.97 mm), with only two women exhibiting thickened endometrium at 6 months, which was confirmed as secretory endometrium via histopathology. No significant changes in blood pressure or biochemical parameters were observed. Challenges in follow-up and biochemical testing arose due to the COVID-19 pandemic.
CONCLUSION: Centchroman appears to be an effective and affordable non-hormonal contraceptive option, particularly for women contraindicated for hormonal methods. However, pre-emptive counseling regarding potential menstrual side effects is crucial.
METHODS: The prospective observational analytical study was conducted across six centers in India from June 2019 to May 2023. A mixed cohort of 3139 women who opted for Centchroman out of 36 625 eligible women were followed up for 24 months.
RESULTS: Mean age of participants was 26 ± 4.4 years. Menstrual abnormalities were the most common side effect, at an average of 1.03-1.17 events per woman. Discontinuation rates were highest within the first 3 months (40.9%) due to menstrual disturbances, notably reduced menstrual flow (60% at 18 months), amenorrhea, heavy or irregular bleeding, and spotting. Life table analysis revealed continuation rates of 78.0%, 47.3%, and 32.2% at 6 weeks, 6 months, and 24 months, respectively. Overall satisfaction from 6 weeks to 12 months after initiation was 75.2%. Failure rate ranged from 0.7%-2.1%. Mean endometrial thickness remained stable throughout the study period (6.54 ± 2.49 to 7.80 ± 1.97 mm), with only two women exhibiting thickened endometrium at 6 months, which was confirmed as secretory endometrium via histopathology. No significant changes in blood pressure or biochemical parameters were observed. Challenges in follow-up and biochemical testing arose due to the COVID-19 pandemic.
CONCLUSION: Centchroman appears to be an effective and affordable non-hormonal contraceptive option, particularly for women contraindicated for hormonal methods. However, pre-emptive counseling regarding potential menstrual side effects is crucial.