A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF LUTEAL-PHASE DYDROGESTERONE (DUPHASTON) IN WOMEN WITH MINIMAL TO MILD ENDOMETRIOSIS

Objective: To compare dydrogesterone with placebos in the treatment of minimal to mild endometriosis. Design: Prospective, double-blind, ran domized study. Setting: Three Obstetrics and Gynaecology Departments i n the United Kingdom. Patients: Sixty-two premenopausal women with com plaints of pain (n = 12) and infertility with or without pain (n = 50) with minimal to mild endometriosis diagnosed at laparoscopy. Thirty-n ine women had a laparoscopy after treatment and 56 women were followed up 12 months after treatment. Interventions: Two high doses of dydrog esterone (either 40 or 60 mg) or a placebo, which was given for 12 day s, beginning 2 days after the LH surge for a treatment period of 6 mon ths. Main Outcome Measures: Change between before and after treatment endometriosis scores, pregnancy rates (PRs), and pain. Results: Treatm ent with dydrogesterone did not alter the natural history of endometri osis or PRs when compared with placebo. Pain was reduced significantly during treatment with 60 mg dydrogesterone and this improvement still was evident at 12-month follow-up. Conclusion: Luteal phase dydrogest erone reduces pain associated with endometriosis.