OBJECTIVE: To compare the effects of anastrozole and clomiphene citrate (CC) on follicular development and ovulation in infertile women with ovulatory dysfunction. DESIGN: Phase II, prospective, randomized, assessor-blind, multicenter, dose-finding, noninferiority study. SETTING: Outpatient. PATIENT(S): Infertile women with ovulatory dysfunction, aged 18-35 years, and body mass index <35 kg/m(2). INTERVENTION(S): Single-dose anastrozole at 5 mg (n = 39), 10 mg (n = 39), 20 mg (n = 39), or 30 mg (n = 38) or a 5-day course of CC at 50 mg/d (n = 39) as starting doses. MAIN OUTCOME MEASURE(S): The primary endpoint was the ovulation rate in the first treatment cycle (cycle 1). Ovulation was defined as a midluteal phase serum P level ≥ 10 ng/mL or clinical pregnancy. RESULT(S): In cycle 1 the ovulation rates for a single dose of anastrozole at 5, 10, 20, and 30 mg were 46.2%, 41.0%, 23.1%, and 28.9%, respectively, whereas that for CC at 50 mg/d was 61.5%. Among women with fewer than six menses per year, the cumulative ovulation rates over three cycles were comparable in the anastrozole 5 mg (52.4%) and CC 50 mg/d (42.3%) groups. CONCLUSION(S): In terms of ovulation rates in cycle 1, single-dose anastrozole at 5, 10, 20, and 30 mg was not as effective as CC at 50 mg/d for 5 days (noninferiority was not shown).
RCT Entities:
OBJECTIVE: To compare the effects of anastrozole and clomiphene citrate (CC) on follicular development and ovulation in infertile women with ovulatory dysfunction. DESIGN: Phase II, prospective, randomized, assessor-blind, multicenter, dose-finding, noninferiority study. SETTING:Outpatient. PATIENT(S): Infertile women with ovulatory dysfunction, aged 18-35 years, and body mass index <35 kg/m(2). INTERVENTION(S): Single-dose anastrozole at 5 mg (n = 39), 10 mg (n = 39), 20 mg (n = 39), or 30 mg (n = 38) or a 5-day course of CC at 50 mg/d (n = 39) as starting doses. MAIN OUTCOME MEASURE(S): The primary endpoint was the ovulation rate in the first treatment cycle (cycle 1). Ovulation was defined as a midluteal phase serum P level ≥ 10 ng/mL or clinical pregnancy. RESULT(S): In cycle 1 the ovulation rates for a single dose of anastrozole at 5, 10, 20, and 30 mg were 46.2%, 41.0%, 23.1%, and 28.9%, respectively, whereas that for CC at 50 mg/d was 61.5%. Among women with fewer than six menses per year, the cumulative ovulation rates over three cycles were comparable in the anastrozole 5 mg (52.4%) and CC 50 mg/d (42.3%) groups. CONCLUSION(S): In terms of ovulation rates in cycle 1, single-dose anastrozole at 5, 10, 20, and 30 mg was not as effective as CC at 50 mg/d for 5 days (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: 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