LIPT - Liraglutide in Polycystic Ovary Syndrome

Cardiovascular Disease Clinical Trial

— LIPT  

Official title:

A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073929
• Other study ID #: EudraCT nr 2013-003862-15
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.

The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.

70 women will be included in af RCT.

Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• PCOS

• >18 years

• premenopausal

• BMI >25 og 25 and thereunder + insulin resistent

Exclusion Criteria (including):

• actualt or intended pregnancy

• inadeqvat contraception

• hormonal contraception within 6 weeks

• metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months

• medications affectiv hemostatic mechanisme

• diabetes or other severe comorbidity

• familar MEN

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Liraglutide for 26 weeks
GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks
• placebo
Placebo s.c. daily for 26 weeks

Locations

Country	Name	City	State
Denmark	Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital	Herlev
Denmark	Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital	Herlev
Denmark	Herlev Hospital, Dept of Gynecology	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Jens Faber

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Plasma Level of Adrenomedullin	measured in nmol/l	at time 0 and 26 weeks
Other	Change in Plasma Level of Atrial Natriuretic Peptide (ANP)	measured in pmol/l	at time 0 and 26 weeks
Other	Change in Plasma Level of Copeptin		at time 0 and 26 weeks
Other	Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)	percent change from baseline	at time 0 and 26 weeks
Other	Change in Bleeding Pattern (Bleeding Ratio)	Ration between number of bleedings during 3 months before trial and last 3 months of trial	at time 0 and 26 weeks
Other	Change in Percent Liver Fat Content	percent liver fat content	at time 0 and 26 weeks
Other	Change in Body Composition (VAT)	cubic cm	at time 0 and 26 weeks
Other	Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)	measured as ml	at time 0 and 26 weeks
Other	Change in Serum Levels of Anti-Müllerian Hormone	measured as pmol/l	at time 0 and 26 weeks
Primary	Change in Endogenous Thrombin Potential (ETP)	Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min	at time 0 and 26 weeks
Secondary	Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1		at time 0 and 26 weeks