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

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.