title: Anastrozole single-dose protocol in women with oligo- or anovulatory infertility: results of a randomized phase II dose-response study.
abstract: OBJECTIVE
  To compare the effects of anastrozole and clomiphene citrate (CC) on follicular development and ovulation in infertile women with ovulatory dysfunction.
  
  
  METHODS
  Phase II, prospective, randomized, assessor-blind, multicenter, dose-finding, noninferiority study.
  
  
  METHODS
  Outpatient.
  
  
  METHODS
  Infertile women with ovulatory dysfunction, aged 18-35 years, and body mass index <35 kg/m(2).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.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; D000858:Anovulation / Q000150:complications / Q000188:drug therapy*; D002996:Clomiphene / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007247:Infertility, Female / Q000188:drug therapy* / Q000209:etiology; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods; D011247:Pregnancy; D018873:Pregnancy Rate; D016037:Single-Blind Method; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D005300:Fertility Agents, Female; D009570:Nitriles; D014230:Triazoles; D002996:Clomiphene; D000077384:Anastrozole