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

September 21, 2017 updated by: EMD Serono

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Rockland, Massachusetts, United States, 02370
        • Local US Medical Information

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clomiphene Citrate 50 Milligram (mg)
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).
Active Comparator: Clomiphene Citrate 100 mg
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).
Experimental: Anastrozole 1 mg
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).
Experimental: Anastrozole 5 mg
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).
Experimental: Anastrozole 10 mg
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2005

Primary Completion (Actual)

December 12, 2007

Study Completion (Actual)

December 12, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anovulation

Clinical Trials on Clomiphene Citrate 50 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe