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| Sponsored by: |
University Magna Graecia |
|---|---|
| Information provided by: | University Magna Graecia |
| ClinicalTrials.gov Identifier: | NCT00501904 |
Purpose
Metformin, an oral biguanide administrated for treating type-2 diabetes mellitus, is a safe and effective drug recently experimented also in patients with polycystic ovary syndrome (PCOS). The administration of metformin induces ovulatory cycles in CC-resistant or -nonresistant patients with PCOS, and improves the ovulation rate as an additional treatment in women who received CC.
To date, it is unknown the best protocol for metformin administration. In particular, it is not known how long patients who ovulate under metformin should continue treatment before switching to second-line ovulation induction therapy. In this regard, in a recent study by the Kaplan-Meier survival analysis we demonstrated that the first pregnancy occurred late after metformin with an estimated median of seven months.
Based on these considerations, the aim of the present study will be to evaluate the clinical efficacy of metformin according to its duration of administration in infertile PCOS patients ovulating under treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Ovary Syndrome |
Drug: Metformin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy of Long- Versus Short-Term Metformin Protocol in Infertile Anovulatory PCOS Patients |
Infertile PCOS patients having three ovulatory cycles under metformin, administered using tailored protocol, will be enrolled and randomized in two groups (groups A and B). Patients of group A will continue metformin administration for further three cycles followed by six months of progestogens cyclically administered, whereas patients of group B will continue metformin therapy for further nine cycles.
All patients eligible will undergo baseline assessment consisting of anthropometric, hormonal, and ultrasonographic evaluations. During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant. Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required. For categorical variables, the Pearson chi-square and Fisher’s exact tests will be used. Cumulative pregnancy rate, our primary end-point, will be calculated by the Kaplan-Maier method, and the differences between the two groups will be assessed with the log-rank test. Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stefano Palomba, MD | +39-0961-883234 | stefanopalomba@tin.it |
| Italy, Catanzaro, CZ, Italy | |
| Pugliese Hospital | Recruiting |
| Catanzaro, Catanzaro, CZ, Italy, Italy, 88100 | |
| Contact: Ingrid Tomaino, MD +39-0961965097 angela.falbo@libero.it | |
| Principal Investigator: Stefano Palomba, MD | |
| Principal Investigator: | Stefano Palomba, MD | Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro |
| Principal Investigator: | Francesco Orio, MD | Department of Endocrinology, University “Federico II” of Naples |
| Principal Investigator: | Achille Tolino, MD | Department of Obstetrics & Gynecology, University “Federico II” of Naples |
More Information
| Study ID Numbers: | 05/2006b |
| Study First Received: | July 12, 2007 |
| Last Updated: | July 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00501904 |
| Health Authority: | Italy: The Italian Medicines Agency |
|
Anovulation Infertility Metformin PCOS Treatment |
|
Genital Diseases, Female Infertility Gonadal Disorders Metformin Polycystic Ovary Syndrome Endocrine System Diseases |
Endocrinopathy Ovarian Diseases Cysts Anovulation Ovarian Cysts |
|
Neoplasms Hypoglycemic Agents Pathologic Processes Disease |
Syndrome Physiological Effects of Drugs Pharmacologic Actions Adnexal Diseases |
