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

NCT ID: NCT00213148

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-10
• Study Completion Date: 2007-12-12

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.

Conditions

Anovulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Clomiphene Citrate 50 Milligram (mg)

Group Type: ACTIVE_COMPARATOR

Clomiphene Citrate 50 mg

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Clomiphene Citrate 100 mg

Intervention Type: 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).

Anastrozole 1 mg

Group Type: EXPERIMENTAL

Anastrozole 1 mg

Intervention Type: 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

Group Type: EXPERIMENTAL

Anastrozole 5 mg

Intervention Type: 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

Group Type: EXPERIMENTAL

Anastrozole 10 mg

Intervention Type: 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).

Interventions

Anastrozole 1 mg

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).

Intervention Type: DRUG

Anastrozole 5 mg

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).

Intervention Type: DRUG

Anastrozole 10 mg

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).

Intervention Type: DRUG

Clomiphene Citrate 50 mg

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).

Intervention Type: DRUG

Clomiphene Citrate 100 mg

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Locations

Local US Medical Information

Rockland, Massachusetts, United States

Countries

United States

Other Identifiers

25550

Identifier Type: -

Identifier Source: org_study_id