Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451568
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2007-03-22
Brief Title:
Metformin and Oral Contraceptives in PCOS
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Metformin and Oral Contraceptives in PCOS
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Background PCOS is a common condition with a prevalence of 5-8 in premenopausal women More than 50 of PCOS patients are insulin resistant and have a diabetes risk 5-8 times higher than age- and weight-matched controls Studies using insulin sensitizers in PCOS found increased insulin sensitivity and decreased insulin levels to be followed by decreased androgen levels and improved ovulatory function No studies however evaluated the long term effects of insulin sensitizing treatment
Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS
Design Randomized open study in 330 PCOS patients Patients are randomised to 24 months of treatment with 1 metformin 2 metformin and oral contraceptives or 3 oral contraceptives
Primary outcome measures fasting insulin AUC insulin Secundary endpoints BMI WHR LH FSH total and free-testosterone c-peptid urinary cortisol AUC for insulin glucose and c-peptid during OGTT
Inclusioncriteria
1 Irregular menses or anovulaty cycles
2 High free testosterone 0035 nmoll or hirsutism
3 PCO in vaginal US Criteria 1 and 2 OR 2 and 3
Design
Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS
Design Randomized open study in 330 PCOS patients Patients are randomised to 24 months of treatment with 1 metformin 2 metformin and oral contraceptives or 3 oral contraceptives
Primary outcome measures fasting insulin AUC insulin Secundary endpoints BMI WHR LH FSH total and free-testosterone c-peptid urinary cortisol AUC for insulin glucose and c-peptid during OGTT
Inclusioncriteria
1 Irregular menses or anovulaty cycles
2 High free testosterone 0035 nmoll or hirsutism
3 PCO in vaginal US Criteria 1 and 2 OR 2 and 3
Design
Detailed Description:
90 patients are included and randomized to 12 months of treatment with metformin 10001000 mgd or OCP 150 mg desogestrel 30 microgram ethinylestradiol or combined treatment metforminOCP
Patients attend a biochemical and physical examination at study inclusion and at 12 months Patients attend for registration of side effects and compliance after 6 months of study duration Safety tests are performed at all three visits and include weight blood pressure HbA1c liver enzymes electrolytes and white blood cell count Pregnancy tests are performed by the participants each month Patients are given general advice on lifestyle intervention Patients are excluded if they initiated medical treatment with possible hormonal and metabolic effects during the intervention period Lifestyle intervention is allowed Laser treatment is offered to patients with moderate or severe facial hirsutism and patients are allowed to shavewax The patients accept not applying cosmetic treatment 3-4 days before attending for evaluation at the clinic
Patients attend a biochemical and physical examination at study inclusion and at 12 months Patients attend for registration of side effects and compliance after 6 months of study duration Safety tests are performed at all three visits and include weight blood pressure HbA1c liver enzymes electrolytes and white blood cell count Pregnancy tests are performed by the participants each month Patients are given general advice on lifestyle intervention Patients are excluded if they initiated medical treatment with possible hormonal and metabolic effects during the intervention period Lifestyle intervention is allowed Laser treatment is offered to patients with moderate or severe facial hirsutism and patients are allowed to shavewax The patients accept not applying cosmetic treatment 3-4 days before attending for evaluation at the clinic
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