Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients...
Date First Received: May 8, 2007
Last Updated: May 8, 2007
Verified by: University Magna Graecia, May 2007
Clinical Trial Phase: Phase 4 | Start Date: May 2006
Overall Status: Completed
Estimated Enrollment: 80
Brief Summary
Official Title: “Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome”
Condition Keyword(s):
Intervention(s):
Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups). Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months. During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.
Intervention(s) in this Clinical Trial
- Drug: Clomiphene citrate
- Drug: Metformin
Outcome Measures for this Clinical Trial
Primary Measures
- Pregnancy rate
- Time Frame: 10 months
- Time Frame: 10 months
Secondary Measures
- Ovulation rate
- Time Frame: 6 months
- Time Frame: 6 months
- Abortion rate
- Time Frame: 10 months
- Time Frame: 10 months
- Time to first pregnancy
- Time Frame: 10 months
- Time Frame: 10 months
- Adverse events
- Time Frame: 10 months
- Time Frame: 10 months
- N. pregnancies/n. ovulatory cycles
- Time Frame: 10 months
- Time Frame: 10 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Anovulatory infertility related to polycystic ovary syndrome
Exclusion Criteria:
- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
- Hypothyroidism, hyperprolactinemia, Cushing’s syndrome, and non-classical congenital adrenal hyperplasia
- Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
- Organic pelvic diseases
- Previous pelvic surgery
- Suspected peritoneal factor infertility
- Tubal or male factor infertility or sub-fertility
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 41 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Magna Graecia
Overall Clinical Trial Officials and Contacts
Stefano Palomba, MD Principal Investigator Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro
Related Publications
References
Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. Epub 2005 Apr 19.
Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. Epub 2006 Oct 30.
Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7.
Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. Epub 2006 Jul 10.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00471523
Study ID Number: 02-2006
ClinicalTrials.gov Identifier: NCT00471523
Health Authority: Italy: The Italian Medicines Agency
Clinical Trials Authorship and Review
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