LIPT - Liraglutide in Polycystic Ovary Syndrome

Jens Faber

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome; Cardiovascular Disease

Treatments: Drug: placebo; Drug: Liraglutide for 26 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT02073929

EudraCT nr 2013-003862-15

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• ...

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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

Treatment:

Drug: Liraglutide for 26 weeks

Placebo

Placebo Comparator group

Description:

Placebo s.c. daily for 26 weeks

Treatment:

Drug: placebo