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OpenTrials
Completed

NCT Number: NCT00213148

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

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.

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Key information

Conditions

Anovulation Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Local US Medical Information

Rockland, Massachusetts, 02370, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-40 years
  • Ovulatory dysfunction characterized by irregular and/or extended cycles
  • Non-smoker

Exclusion criteria

  • No previous gonadotropin treatment
  • No more than 6 previous clomiphene treatment cycles

Treatment and study plan

Anastrozole 1 mg

Drug

Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Anastrozole 5 mg

Drug

Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Anastrozole 10 mg

Drug

Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Clomiphene Citrate 50 mg

Drug

Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).

Clomiphene Citrate 100 mg

Drug

Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).

Primary outcomes

  1. Ovulation Rate in Cycle 1

    Time frame: Up to 1 month

    Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy).

Secondary outcomes

  1. Number of Subjects With Clinical Pregnancy in Cycle 1

    Time frame: Up to 1 month

    Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study 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 Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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