OBJECTIVE: To determine an effective multiple-dose regimen of anastrozole compared with clomiphene citrate (CC) to induce follicular growth and ovulation in infertile women with ovulatory dysfunction. DESIGN: Phase II, prospective, randomized, double-blind, multicenter, dose-finding, noninferiority study. SETTING: Outpatient. PATIENT(S): Infertile women (n = 271) with ovulatory dysfunction, aged 18-40 years, with body mass index <37 kg/m(2). INTERVENTION(S): Five days of anastrozole at 1, 5, or 10 mg/d or CC at 50 mg/d. MAIN OUTCOME MEASURE(S): The primary endpoint was the ovulation rate (mid-luteal phase serum P level ≥ 10 ng/mL or clinical pregnancy) in the first treatment cycle (cycle 1). RESULT(S): In cycle 1 the ovulation rates for anastrozole at 1, 5, and 10 mg/d were 30.4% (n = 24), 36.8% (n = 28), and 35.9% (n = 14), respectively, compared with 64.9% (n = 50) for CC at 50 mg/d. In up to three cycles of treatment, cumulative ovulation rates did not differ between groups. No cases of ovarian hyperstimulation syndrome were reported, and both anastrozole and CC were well tolerated. CONCLUSION(S): In terms of ovulation rates, 5-day anastrozole at 1, 5, and 10 mg/d was less effective than CC at 50 mg/d for cycle 1 (noninferiority was not shown).
RCT Entities:
OBJECTIVE: To determine an effective multiple-dose regimen of anastrozole compared with clomiphene citrate (CC) to induce follicular growth and ovulation in infertile women with ovulatory dysfunction. DESIGN: Phase II, prospective, randomized, double-blind, multicenter, dose-finding, noninferiority study. SETTING:Outpatient. PATIENT(S): Infertile women (n = 271) with ovulatory dysfunction, aged 18-40 years, with body mass index <37 kg/m(2). INTERVENTION(S): Five days of anastrozole at 1, 5, or 10 mg/d or CC at 50 mg/d. MAIN OUTCOME MEASURE(S): The primary endpoint was the ovulation rate (mid-luteal phase serum P level ≥ 10 ng/mL or clinical pregnancy) in the first treatment cycle (cycle 1). RESULT(S): In cycle 1 the ovulation rates for anastrozole at 1, 5, and 10 mg/d were 30.4% (n = 24), 36.8% (n = 28), and 35.9% (n = 14), respectively, compared with 64.9% (n = 50) for CC at 50 mg/d. In up to three cycles of treatment, cumulative ovulation rates did not differ between groups. No cases of ovarian hyperstimulation syndrome were reported, and both anastrozole and CC were well tolerated. CONCLUSION(S): In terms of ovulation rates, 5-day anastrozole at 1, 5, and 10 mg/d was less effective than CC at 50 mg/d for cycle 1 (noninferiority was not shown).
Authors: Richard S Legro; Allen R Kunselman; Robert G Brzyski; Peter R Casson; Michael P Diamond; William D Schlaff; Gregory M Christman; Christos Coutifaris; Hugh S Taylor; Esther Eisenberg; Nanette Santoro; Heping Zhang Journal: Contemp Clin Trials Date: 2012-01-13 Impact factor: 2.226
Authors: Selma F Witchel; Sergio E Recabarren; Frank González; Evanthia Diamanti-Kandarakis; Kai I Cheang; Antoni J Duleba; Richard S Legro; Roy Homburg; Renato Pasquali; Rogerio A Lobo; Christos C Zouboulis; Fahrettin Kelestimur; Franca Fruzzetti; Walter Futterweit; Robert J Norman; David H Abbott Journal: Endocrine Date: 2012-06-04 Impact factor: 3.633
Authors: Richard S Legro; Robert G Brzyski; Michael P Diamond; Christos Coutifaris; William D Schlaff; Peter Casson; Gregory M Christman; Hao Huang; Qingshang Yan; Ruben Alvero; Daniel J Haisenleder; Kurt T Barnhart; G Wright Bates; Rebecca Usadi; Scott Lucidi; Valerie Baker; J C Trussell; Stephen A Krawetz; Peter Snyder; Dana Ohl; Nanette Santoro; Esther Eisenberg; Heping Zhang Journal: N Engl J Med Date: 2014-07-10 Impact factor: 91.245