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Sponsored by: |
Derby Hospitals NHS Foundation Trust |
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Information provided by: | Derby Hospitals NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00478504 |
The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.
Condition | Intervention | Phase |
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Infertility Polycystic Ovarian Syndrome |
Drug: Letrozole Drug: Clomifene citrate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Double Blind Cross-Over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome |
Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PCOS: At least two of the following diagnostic criteria of:
Exclusion Criteria:
Contact: Saad Amer, MD, MRCOG | +44(1332)724612 | saad.amer@nottingham.ac.uk |
United Kingdom, Derbyshire | |
Derby City General Hospital | Recruiting |
Derby, Derbyshire, United Kingdom, DE22 3NE | |
Contact: Saad Amer, MD, MRCOG +44(1332)724612 saad.amer@nottingham.ac.uk |
Principal Investigator: | Saad Amer, MD, MRCOG | University of Nottingham and Derby Hospitals NHS foundation Trust |
Study ID Numbers: | RD-5103-015-06, EudraCT No: 2006-006514-15 |
Study First Received: | May 23, 2007 |
Last Updated: | May 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00478504 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; United Kingdom: National Health Service |
anovulation ovulation induction, polycystic ovarian syndrome clomifene citrate letrozole |
Infertility Gonadal Disorders Citric Acid Endocrine System Diseases Clomiphene Letrozole Ovarian Diseases |
Genital Diseases, Male Cysts Genital Diseases, Female Polycystic Ovary Syndrome Endocrinopathy Anovulation Ovarian Cysts |
Estrogen Antagonists Disease Anticoagulants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hematologic Agents 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 Fertility Agents, Female Syndrome Therapeutic Uses Fertility Agents Chelating Agents Aromatase Inhibitors |