Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437333
Status:
COMPLETED
Last Update Posted:
2007-02-21
First Post:
2007-02-20
Brief Title:
Metformin Suspension and Insulin Sensitivity
Sponsor:
University Magna Graecia
Organization:
University Magna Graecia
Study Overview
Official Title:
Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome PCOS To date the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension
The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients
The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients
Detailed Description:
Thirty young normal-weight anovulatory PCOS women will be enrolled The diagnosis of PCOS will be based on the presence of clinical Ferriman-Gallwey score 8 or biochemical hyperandrogenism serum testosterone levels 2 SD above our reference mean values and chronic anovulation serum luteal progesterone P below 2 ngmL
Patients will be randomly allocated into two groups metformin and placebo group using a computer-software Fifteen PCOS patients will be treated with metformin at a dosage of 1700 mg daily one tablet of 850 mg twice daily metformin group whereas other 15 PCOS will be treated with placebo tables one tablet twice daily placebo group The duration of the treatment will be 12 months Patients will be instructed to follow their usual diet and physical activity and to use barrier contraception throughout the study The length and the frequency of the menstrual cycles and the adverse experiences AEs will be reported on a daily diary
Each subject will undergo follow-up visits under at six and 12 months from treatment starting and after treatment at six and 12 months from treatment withdrawal At each follow-up visit in all subjects the same operator will perform clinical hormonal metabolic and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp
Patients will be randomly allocated into two groups metformin and placebo group using a computer-software Fifteen PCOS patients will be treated with metformin at a dosage of 1700 mg daily one tablet of 850 mg twice daily metformin group whereas other 15 PCOS will be treated with placebo tables one tablet twice daily placebo group The duration of the treatment will be 12 months Patients will be instructed to follow their usual diet and physical activity and to use barrier contraception throughout the study The length and the frequency of the menstrual cycles and the adverse experiences AEs will be reported on a daily diary
Each subject will undergo follow-up visits under at six and 12 months from treatment starting and after treatment at six and 12 months from treatment withdrawal At each follow-up visit in all subjects the same operator will perform clinical hormonal metabolic and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Prot 2004063411_003 | None | None | None |