Assessment of the prescription pattern of dydrogesterone in obstetrics and gynaecological disorders in adult women in an outpatient setting across India

Abstract

Background: Dydrogesterone is a prescribed progestogen used in infertility, threatened abortion, recurrent pregnancy loss, endometriosis, and menstrual disorders. However, large-scale real-world evidence describing its utilisation patterns in clinical practice in India remains limited.

Methods: This multicentric, cross-sectional, observational study included adult women receiving dydrogesterone therapy across India. Data on demographic and reproductive characteristics, clinical indications, comorbidities, treatment regimens, and duration of therapy were collected from routine clinical records and analysed using descriptive and inferential statistics.

Results: A total of 7,160 women were included. Infertility was the most common indication for dydrogesterone therapy (45.0%; n=3219), followed by threatened abortion (27.2%; n=1946) and recurrent pregnancy loss (13.6%; n=972). Dydrogesterone 10 mg twice daily was the most frequently prescribed regimen (49.8%; n=3564), followed by Dydrogesterone 10 mg once daily (30.9%; n=2211) and sustained-release 20 mg once daily (12.4%; n=886). Most patients were aged 18-30 years (73.4%; n=5256), had a normal body mass index (58.9%; n=4218), and were nulligravida (89.3%; n=6394). Significant associations were observed between treatment regimen and clinical indication, age category, body mass index, gravida status, parity status, comorbidity status, and duration of therapy (all p<0.05).

Conclusions: This large multicentric real-world study demonstrates extensive utilisation of dydrogesterone in Indian obstetric and gynaecological practice, with 10 mg twice-daily and once-daily regimens representing the predominant treatment approaches. The findings provide valuable real-world evidence on patient profiles and contemporary prescribing patterns associated with dydrogesterone use in routine clinical care.