Back to resultsComparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Primary Purpose
Anovulation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anastrozole 1 mg
Anastrozole 5 mg
Anastrozole 10 mg
Clomiphene Citrate 50 mg
Clomiphene Citrate 100 mg
Sponsored by
About this trial
This is an interventional treatment trial for Anovulation
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
Sites / Locations
- Local US Medical Information
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Clomiphene Citrate 50 Milligram (mg)
Clomiphene Citrate 100 mg
Anastrozole 1 mg
Anastrozole 5 mg
Anastrozole 10 mg
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00213148
Brief Title
Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 10, 2005 (Actual)
Primary Completion Date
December 12, 2007 (Actual)
Study Completion Date
December 12, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anovulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clomiphene Citrate 50 Milligram (mg)
Arm Type
Active Comparator
Arm Title
Clomiphene Citrate 100 mg
Arm Type
Active Comparator
Arm Title
Anastrozole 1 mg
Arm Type
Experimental
Arm Title
Anastrozole 5 mg
Arm Type
Experimental
Arm Title
Anastrozole 10 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anastrozole 1 mg
Intervention Description
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
Intervention Name(s)
Anastrozole 5 mg
Intervention Description
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
Intervention Name(s)
Anastrozole 10 mg
Intervention Description
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
Intervention Name(s)
Clomiphene Citrate 50 mg
Intervention Description
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
Intervention Name(s)
Clomiphene Citrate 100 mg
Intervention Description
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 Outcome Measure Information:
Title
Ovulation Rate in Cycle 1
Description
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).
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Number of Subjects With Clinical Pregnancy in Cycle 1
Description
Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.
Time Frame
Up to 1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Local US Medical Information
City
Rockland
State/Province
Massachusetts
ZIP/Postal Code
02370
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
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