Clinical outcomes among Centchroman users across six medical college hospitals in India.

Abstract

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.