Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome

Abstract

Objective: To compare the ovulation rate between raloxifene and clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).

Design: Double-blind, randomized, superiority clinical trial.

Setting: Tertiary university hospital.

Patient(s): Women with ovulatory dysfunction and PCOS based on the Rotterdam criteria.

Intervention(s): One of two oral treatments: 5 days of 100 mg/day of CC or R.

Main outcome measure(s): Ovulation, based on follicle collapse on serial ultrasound and midsecretory serum progesterone concentration (≥3 ng/dL).

Result(s): The women with PCOS (n = 82) were randomized to receive CC (n = 40) or raloxifene (n = 42). From these, 68 patients finished the trial according to the protocol (CC: n = 37; raloxifene: n = 31). There were no statistically significant differences between the groups in ovulation rates per an intention-to-treat analysis based on ultrasound alone (CC: 21 of 40 vs. raloxifene: 17 of 42) or on progesterone levels (CC: 16 of 40 vs. raloxifene: 11 of 42). No serious adverse events were observed in either group.

Conclusion(s): No statistically significant difference in ovulation was observed between raloxifene and clomiphene citrate in patients with PCOS with ovulatory dysfunction.

Trial registration: ClinicalTrials.gov NCT00427700.