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Sponsors and Collaborators: |
Yale University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Penn State University University of Colorado at Denver and Health Sciences Center University of Michigan University of Pennsylvania University of Texas University of Vermont Wayne State University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00719186 |
The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child.
Secondary research hypotheses include:
Condition | Intervention | Phase |
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Pregnancy Polycystic Ovary Syndrome |
Drug: Clomiphene citrate Drug: Letrozole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome |
Estimated Enrollment: | 750 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
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Drug: Clomiphene citrate
Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
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B: Active Comparator
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
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Drug: Letrozole
Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks
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Preliminary data are promising for the use of letrozole to induce ovulation in infertile women with PCOS. However the true magnitude of the effect of letrozole is difficult to discern from prior studies. Therefore we intend to determine the safety and efficacy of letrozole, an aromatase inhibitor, compared to clomiphene citrate, a selective estrogen receptor modulator, in achieving live birth in infertile women with PCOS.
Treatment- After progestin withdrawal, 750 women will be equally randomized to two different treatment arms: A) clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), or B) letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks. Dose will be increased in subsequent cycles in both treatment groups for non-response or poor ovulatory response up to a maximum of 150 mg of clomiphene a day (x 5 days) or 7.5 mg of letrozole a day (x 5 days).
Statistical Analysis- The primary analysis will use an intent-to-treat approach to examine differences in the live birth rate in the two treatment arms.
Anticipated time to completion- A total of 4 years will be required to complete the study after start up; 31 month enrollment period, 5 month treatment period, with 9 month additional observation to determine pregnancy outcomes. This will be accomplished by enrolling ~3.45 women with PCOS per center per month over the enrollment period (N = 7 RMN sites).
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
The patient population will consist of 750 infertile women with PCOS with ovulatory dysfunction and either one of the remaining two criteria, hyperandrogenism (clinical or biochemical) or polycystic ovaries on ultrasound, with exclusion of secondary causes of PCOS. Additionally, the couple will have no other major infertility factor, and the subject will have at least one patent fallopian tube and a normal uterine cavity, and a partner with a sperm concentration of 14 million/mL in at least one ejaculate.
Inclusion Criteria:
Key Inclusion Criteria (Must have ovulatory dysfunction and either hyperandrogenism or PCO)
Hyperandrogenism (either Hirsutism or Hyperandrogenemia) or Polycystic Ovaries on Ultrasound:
Exclusion Criteria:
Contact: Heping Zhang, PHD | (203) 785-5185 | rmn-Coordinators@masal.med.yale.edu |
Contact: Meizhuo Zhang, PHD | (203) 785-6759 | meizhuo.zhang@yale.edu |
United States, Colorado | |
University of Colorado | |
Aurora,, Colorado, United States, 80045 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06511 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, Pennsylvania | |
Pennsylvania State University College of Medicine | |
Hershey, Pennsylvania, United States, 17033 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229 | |
United States, Vermont | |
University of Vermont | |
Burlington, Vermont, United States, 05405 |
Study Director: | Esther Eisenberg, MD, MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Study Chair: | Nanette Santoro, MD | Albert Einstein College of Medicine of Yeshiva University |
Principal Investigator: | Richard Legro, MD | Pennsylvania State University College of Medicine |
Study Director: | Robert Brzyski, MD, PhD | University of Texas |
Study Director: | Peter Casson, MD | University of Vermont |
Study Director: | Michael Diamond, MD | Wayne State University |
Study Director: | Heping Zhang, PhD | Yale University |
Study Director: | Gregory M Christman, MD | University of Michigan |
Study Director: | Christos Coutifaris, MD | University of Pennsylvania |
Study Director: | William D Schlaff, MD | University of Colorado Denver Health Science Center |
Responsible Party: | Penn State University Hershey Medical Center ( Richard Legro, MD, Professor ) |
Study ID Numbers: | RMN-PPCOSII |
Study First Received: | July 17, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00719186 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Polycystic Ovary Syndrome Infertility Pregnancy Women |
Genital Diseases, Female Infertility Gonadal Disorders Citric Acid Polycystic Ovary Syndrome Clomiphene |
Endocrine System Diseases Letrozole Endocrinopathy Ovarian Diseases Cysts Ovarian Cysts |
Estrogen Antagonists Disease Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Reproductive Control Agents Selective Estrogen Receptor Modulators |
Pharmacologic Actions Adnexal Diseases Estrogen Receptor Modulators Neoplasms Pathologic Processes Therapeutic Uses Syndrome Fertility Agents, Female Fertility Agents Aromatase Inhibitors |