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

Anovulation Clinical Trial

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 Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213148
• Other study ID #: 25550
• Status: Completed
• Phase: Phase 2
• Start date: March 10, 2005
• Est. completion date: December 12, 2007

Study information

• Verified date: September 2017
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 12, 2007
• Est. primary completion date: December 12, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anovulation

Intervention

Drug:
• 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).
• 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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Local US Medical Information	Rockland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation Rate in Cycle 1	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).	Up to 1 month
Secondary	Number of Subjects With Clinical Pregnancy in Cycle 1	Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.	Up to 1 month