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Study Topics
Glossary
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Sponsors and Collaborators: |
University of Auckland, New Zealand Auckland Medical Research Foundation Mercia Barnes Research Trust of the Royal Australian & new Zealand College of obstetricians and Gynaecologists University of Auckland Research Committee |
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Information provided by: | University of Auckland, New Zealand |
ClinicalTrials.gov Identifier: | NCT00795808 |
Condition | Intervention | Phase |
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Polycystic Ovary Syndrome |
Drug: Metformin Drug: Placebo Drug: Metformin + Clomiphene Drug: Clomiphene |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome |
Enrollment: | 171 |
Study Start Date: | August 2003 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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BMI > 32: Experimental
Women with BMI > 32
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Drug: Metformin
500mg tds for 6 months
Drug: Placebo
One tablet tds for 6 months
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BMI </= 32: Experimental
Women with BMI </= 32
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Drug: Metformin + Clomiphene
500mg tds + Ovulatory dose for 6 months
Drug: Metformin
500mg tds for 6 months
Drug: Clomiphene
Ovulatory dose for 6 months
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Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
For those women who have had previous fertility treatment, the following would be excluded:
New Zealand | |
University of Auckland | |
Auckland, New Zealand |
Principal Investigator: | Neil P Johnson, FRANZCOG | University of Auckland, fertility Plus & Repromed Auckland |
Responsible Party: | University of Auckland, Fertility Plus and Repromed Auckland ( Associate Professor Neil Johnson ) |
Study ID Numbers: | UAuckland |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795808 |
Health Authority: | New Zealand: Health Research Council |
Polycystic ovary syndrome PCOS Anovulation Infertility Anovulatory polycystic ovary syndrome (PCOS) |
Infertility Gonadal Disorders Citric Acid Metformin Endocrine System Diseases Clomiphene Ovarian Diseases |
Genital Diseases, Male Cysts Genital Diseases, Female Polycystic Ovary Syndrome Endocrinopathy Anovulation Ovarian Cysts |
Estrogen Antagonists Disease Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Adnexal Diseases |
Estrogen Receptor Modulators Neoplasms Hypoglycemic Agents Pathologic Processes Therapeutic Uses Syndrome Fertility Agents, Female Fertility Agents |