Anastrozole single-dose protocol in women with oligo- or anovulatory infertility: Results of a randomized phase II dose-response study

Donald Tredway, Joan C. Schertz, Daena Bock, George Hemsey, Michael Peter Diamond

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

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/m2. 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).

Original languageEnglish (US)
JournalFertility and sterility
Volume95
Issue number5
DOIs
StatePublished - Jan 1 2011
Externally publishedYes

Keywords

  • Anastrozole
  • aromatase inhibitor
  • clinical pregnancy
  • clomiphene citrate
  • ovulation
  • ovulatory dysfunction

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Fingerprint Dive into the research topics of 'Anastrozole single-dose protocol in women with oligo- or anovulatory infertility: Results of a randomized phase II dose-response study'. Together they form a unique fingerprint.

  • Cite this