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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 |
---|---|---|
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: | February 2009 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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
|
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 | Not yet recruiting |
Aurora,, Colorado, United States, 80045 | |
Contact: William Schlaff, MD 303-724-2037 william.schlaff@ucdenver.edu | |
Contact: Cyndi Long, BA (303) 724-2064 cyndi.long@ucdenver.edu | |
Principal Investigator: William Schlaff, MD | |
Sub-Investigator: Randall Meacham, MD | |
United States, Connecticut | |
Yale University | Not yet recruiting |
New Haven, Connecticut, United States, 06511 | |
Contact: Heping Zhang, PhD 203-785-5185 heping.zhang@yale.edu | |
Contact: Meizhuo Zhang, PhD (203) 785-6759 meizhuo.zhang@yale.edu | |
Principal Investigator: Heping Zhang, PhD | |
Sub-Investigator: Robert Makuch, PhD | |
Sub-Investigator: Pasquale Patrizio, MD, MBE | |
Sub-Investigator: Lawrency Scahill, PhD | |
Sub-Investigator: Hugh Taylor, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Bev Marchant 734-998-4973 bevm@umich.edu | |
Contact: Gregory Christman, MD growthh@umich.edu | |
Principal Investigator: Gregory Christman, MD | |
Sub-Investigator: Dana Ohl, MD | |
Sub-Investigator: Senait Fisseha, MD | |
Sub-Investigator: John Randolph, MD | |
Sub-Investigator: Yolanda Smith, MD | |
Sub-Investigator: Anjel Vahratian, PhD, MPH | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Michael Diamond, MD 313-993-4523 mdiamond@med.wayne.edu | |
Contact: Karen Collins, MS (313) 993-8706 kcollins@med.wayne.edu | |
Principal Investigator: Michael Diamond, MD | |
Sub-Investigator: Joel Ager, PhD | |
Sub-Investigator: Stephen Krawetz, PhD | |
Sub-Investigator: Laura Detti, MD | |
Sub-Investigator: Elizabeth Puscheck, MD | |
Sub-Investigator: Frank Yelian, MD, PhD | |
Sub-Investigator: Terri Woodard, MD | |
United States, Pennsylvania | |
Pennsylvania State University College of Medicine | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Richard Legro, MD 717-531-8478 RSL1@PSU.EDU | |
Contact: Jamie Ober, RN (717) 531-6272 JOBER@hmc.psu.edu | |
Principal Investigator: Richard Legro, MD | |
Sub-Investigator: J.C. Trussel, MD | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Christos Coutifaris, MD, PhD 215-662-2977 ccoutifaris@obgyn.upenn.edu | |
Contact: Linda Martino, MSN, CRNP (215) 615-3364 lmartino@obgyn.upenn.edu | |
Principal Investigator: Christos Coutifaris, MD, PhD | |
Sub-Investigator: Kurt Barnhart, MD, MSCE | |
Sub-Investigator: Peter Snyder, MD | |
Sub-Investigator: Mary Sammel, PhD | |
Sub-Investigator: William Stauffer | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Robert Brzyski, MD, PhD 210-567-6121 brzyski@uthscsa.edu | |
Contact: Carann Easton, RN (210) 567-6245 eastonc@uthscsa.edu | |
Principal Investigator: Robert Brzyski, MD, PhD | |
Sub-Investigator: John Case, MD | |
Sub-Investigator: Brad Pollock, PhD, MPH | |
United States, Vermont | |
University of Vermont | Recruiting |
Burlington, Vermont, United States, 05405 | |
Contact: Peter Casson, MD 802-847-3450 peter.casson@vtmednet.org | |
Contact: Jennifer Crossmon (802) 656-2272 jennifer.crossmon@uvm.edu | |
Principal Investigator: Peter Casson, MD | |
Sub-Investigator: Thomas Jackson, MD | |
Sub-Investigator: Taka Ashikaga, PhD | |
Sub-Investigator: Michael Toth, PhD |
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: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00719186 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Polycystic Ovary Syndrome Infertility Pregnancy Women |
Infertility Estrogen Antagonists Estrogens Gonadal Disorders Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Clomiphene Letrozole Ovarian Diseases |
Selective Estrogen Receptor Modulators Cysts Hormones Polycystic Ovarian Syndrome Genital Diseases, Female Estrogen Receptor Modulators Polycystic Ovary Syndrome Endocrinopathy Aromatase Inhibitors Ovarian Cysts |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Clomiphene Letrozole Ovarian Diseases Reproductive Control Agents Selective Estrogen Receptor Modulators Genital Diseases, Female Estrogen Receptor Modulators Pathologic Processes Syndrome |
Therapeutic Uses Aromatase Inhibitors Estrogen Antagonists Disease Endocrine System Diseases Enzyme Inhibitors Cysts Pharmacologic Actions Adnexal Diseases Neoplasms Fertility Agents, Female Polycystic Ovary Syndrome Fertility Agents Ovarian Cysts |