LIPT - Liraglutide in Polycystic Ovary Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Liraglutide s.c. 1,8mg daily for 26 weeks

Group Type ACTIVE_COMPARATOR

Liraglutide for 26 weeks

Intervention Type DRUG

GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks

Placebo

Placebo s.c. daily for 26 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo s.c. daily for 26 weeks

Interventions

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Liraglutide for 26 weeks

GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks

Intervention Type DRUG

placebo

Placebo s.c. daily for 26 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PCOS
* \>18 years
* premenopausal
* BMI \>25 og 25 and thereunder + insulin resistent

Exclusion Criteria

* 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
* ...

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No