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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Anovulation

Treatments: Drug: Clomiphene Citrate 50 mg; Drug: Anastrozole 1 mg; Drug: Anastrozole 10 mg; Drug: Anastrozole 5 mg; Drug: Clomiphene Citrate 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00213148

25550

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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271 participants in 5 patient groups

Clomiphene Citrate 50 Milligram (mg)

Active Comparator group

Treatment:

Drug: Clomiphene Citrate 50 mg

Clomiphene Citrate 100 mg

Active Comparator group

Treatment:

Drug: Clomiphene Citrate 100 mg

Anastrozole 1 mg

Experimental group

Treatment:

Drug: Anastrozole 1 mg

Anastrozole 5 mg

Experimental group

Treatment:

Drug: Anastrozole 5 mg

Anastrozole 10 mg

Experimental group

Treatment:

Drug: Anastrozole 10 mg