Clinical Trial: Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in S

Brief Summary: The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.

Detailed Summary:

This is a multicenter, randomized, double-blind study. Upon the provision of Informed Consent, subjects will be screened for entry during the menstrual cycle prior to the anticipated start of treatment. All screening assessments should be completed within 6 weeks of treatment, unless otherwise noted.

Subjects who meet screening requirements will be equally randomized to one of the three following treatment arms:

  • Anastrozole 1 mg/day for 5 days
  • Anastrozole 5 mg/day for 5 days
  • Clomiphene citrate 50 mg/day for 5 days Treatment will begin at cycle day 2 or 3 of their subsequent menses (cycle day 1 = first day of full bleed).

Subjects will return to the clinic on Stimulation Days 3 or 4 and 6 or 7 (note: Stimulation Day 1 equals the first day of study drug) for blood sampling and ultrasounds. Ultrasound and serum monitoring will be repeated every 2 days thereafter until a lead follicle reaches a mean diameter of ³ 14 mm, and then daily until an LH surge occurs. Monitoring will be discontinued if a lead follicle ³ 14 mm has not developed by Stim Day 18 of the cycle (inadequate treatment cycle) with a serum progesterone being obtained one week after discontinuing monitoring.

A subgroup of subjects will be selected for additional pharmacokinetic and pharmacodynamic analysis during Cycle 1 only. Blood samples will be collected at selected timepoints for analysis of anastrozole/clomiphene citrate, estradiol, FSH, LH, androstendione, and testosterone. This subgroup will consist of approximately 40-50 subjects and will be carried out at predetermined investigative centers.