Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00213148
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

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.

Condition or disease Intervention/treatment Phase
Anovulation Drug: Anastrozole 1 mg Drug: Anastrozole 5 mg Drug: Anastrozole 10 mg Drug: Clomiphene Citrate 50 mg Drug: Clomiphene Citrate 100 mg Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2005
Actual Primary Completion Date : December 12, 2007
Actual Study Completion Date : December 12, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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).




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213148


Locations
Layout table for location information
United States, Massachusetts
Local US Medical Information
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
Layout table for investigator information
Study Director: Medical Responsible EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Layout table for additonal information
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00213148     History of Changes
Other Study ID Numbers: 25550
First Posted: September 21, 2005    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Anovulation
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Anastrozole
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators