Metformin in Pregnancy in Women With Polycystic Ovary Syndrome
Overview[ - collapse ][ - ]
| Purpose | The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation. |
|---|---|
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Catholic University of the Sacred Heart |
| Responsible Party | Catholic University of the Sacred Heart |
| ClinicalTrials.gov Identifier | NCT01594697 |
| First Received | May 7, 2012 |
| Last Updated | May 10, 2012 |
| Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 7, 2012 |
|---|---|
| Last Updated Date | May 10, 2012 |
| Start Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | incidence of gestational diabetes |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin in Pregnancy in Women With Polycystic Ovary Syndrome |
|---|---|
| Official Title | Not Provided |
| Brief Summary | The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin |
| Study Arm (s) | Experimental: metformin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 60 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - age 18-40 yr, - metformin treatment for at least 3 months before entering the pregnancy, - gestational age between 5 and 12 wk Exclusion Criteria: - diabetes mellitus - significant liver or renal impairment - neoplasms and other endocrine diseases - the use of drugs other than metformin able to interfere with glucose and insulin metabolism. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Not Provided |
| Contacts | Not Provided |
| Location Countries | Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01594697 |
|---|---|
| Other Study ID Numbers | 000082011 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Catholic University of the Sacred Heart |
| Study Sponsor | Catholic University of the Sacred Heart |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | May 2012 |
Locations[ + expand ][ + ]
| Catholic University of Sacred Heart | Rome, Italy, 00168 |
|---|