LIPT - Liraglutide in Polycystic Ovary Syndrome

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Cardiovascular Disease
• Interventions: Drug: placebo; Drug: Liraglutide for 26 weeks

• Registration Number: NCT02073929
• Lead Sponsor: Jens Faber

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-28
• Study Start: 2014-03
• Status Verified: 2015-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2017-06-20
• Results First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Results First Posted: 2019-02-28
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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
• ...

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo s.c. daily for 26 weeks
Active	Liraglutide for 26 weeks	Liraglutide s.c. 1,8mg daily for 26 weeks

Primary Outcome Measures

Name	Time	Method
Change in Endogenous Thrombin Potential (ETP)	at time 0 and 26 weeks	Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min

Secondary Outcome Measures

Name	Time	Method
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1	at time 0 and 26 weeks

Trial Locations

Locations (3)

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, Denmark