Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068861
Status:
COMPLETED
Last Update Posted:
2007-10-01
First Post:
2003-09-10
Brief Title:
Treatment of Infertility in Women With Polycystic Ovary Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Pregnancy in Polycystic Ovary Syndrome A 30 Week Double-Blind Randomized Trial of Clomiphene Citrate Metformin XR and Combined Clomiphene CitrateMetformin XR For the Treatment of Infertility in Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polycystic Ovary Syndrome PCOS is a common endocrine disorder affecting up to 10 of women The primary symptoms of PCOS are menstrual irregularities increased body and facial hair acne and infertility This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility
Detailed Description:
PCOS is characterized by excess circulating androgen levels and chronic anovulation The fundamental pathophysiologic defect is unknown but PCOS is characterized by insulin resistance and compensatory hyperinsulinemia Improvements in insulin sensitivity in PCOS women either through lifestyle changes or through pharmaceutical intervention have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS Resumption of ovulation occurs in up to 70 of women treated for PCOS This study will evaluate the safety and effectiveness of clomiphene citrate and metformin XR in achieving a successful pregnancy in infertile PCOS women
Women with PCOS who are seeking pregnancy will be enrolled in this study Women will be randomized to one of three different treatment arms A metformin XR 1000 mg twiceday B clomiphene citrate 50 mg every day for 5 days day 3-7 of cycle or C metformin XR 1000 mg twiceday with clomiphene citrate 50 mgday for 5 days day 3-7 of cycle Women will continue on study medications for 30 weeks 6 treatment cycles or until they become pregnant Progesterone levels will be drawn weekly to monitor ovulation
Women with PCOS who are seeking pregnancy will be enrolled in this study Women will be randomized to one of three different treatment arms A metformin XR 1000 mg twiceday B clomiphene citrate 50 mg every day for 5 days day 3-7 of cycle or C metformin XR 1000 mg twiceday with clomiphene citrate 50 mgday for 5 days day 3-7 of cycle Women will continue on study medications for 30 weeks 6 treatment cycles or until they become pregnant Progesterone levels will be drawn weekly to monitor ovulation
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