title: Anastrozole vs. clomiphene citrate in infertile women with ovulatory dysfunction: a phase II, randomized, dose-finding study.
abstract: 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.
  
  
  METHODS
  Phase II, prospective, randomized, double-blind, multicenter, dose-finding, noninferiority study.
  
  
  METHODS
  Outpatient.
  
  
  METHODS
  Infertile women (n = 271) with ovulatory dysfunction, aged 18-40 years, with body mass index <37 kg/m(2).
  
  
  METHODS
  Five days of anastrozole at 1, 5, or 10 mg/d or CC at 50 mg/d.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Global Clinical Development Unit, EMD Serono, Inc., Rockland, MA 02370, USA.
authors.forename: Donald
authors.initials: D
authors.lastname: Tredway
authors.forename: Joan C
authors.initials: JC
authors.lastname: Schertz
authors.forename: Daena
authors.initials: D
authors.lastname: Bock
authors.forename: George
authors.initials: G
authors.lastname: Hemsey
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
mesh_terms: D000293:Adolescent; D000328:Adult; D000077384:Anastrozole; D002996:Clomiphene / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007247:Infertility, Female / Q000503:physiopathology / Q000628:therapy*; D009570:Nitriles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016471:Ovarian Hyperstimulation Syndrome / Q000453:epidemiology / Q000209:etiology; D010060:Ovulation / Q000187:drug effects / Q000502:physiology; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D005300:Fertility Agents, Female; D009570:Nitriles; D014230:Triazoles; D002996:Clomiphene; D000077384:Anastrozole