Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study

Detailed Summary

In India Duphaston is approved and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual abortion, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. One Indian study reported normalization of the cycle in 91.6% of women with menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from 11th to the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone therapy in this study was noted to be 28.8 days, in contrast to 17.9 days (in the polymenorrhea group) and 50.6 days (in the oligomenorrhea group) before therapy. Furthermore, dydrogesterone also decreased the amount and duration of menstrual bleeding in this study. However, there are limited data regarding Duphaston's role in achieving cycle regularization from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston therapy persists after cessation of treatment and whether the persistent effect, if any, is related to the duration of Duphaston therapy. Hence, in this observational study, given that (based on previous clinical studies as mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is to tease out the possible implications of such treatment in terms of treatment length and response pattern.

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