LIPT - Liraglutide in Polycystic Ovary Syndrome

Sponsor
Jens Faber
Study ID
NCT02073929
Phase
PHASE4
Status
Completed

Conditions

  • Cardiovascular Disease
  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2014
Status verified
Jun 2015
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
    Liraglutide s.c. 1,8mg daily for 26 weeks
  • Placebo Comparator: Placebo
    Placebo s.c. daily for 26 weeks

Primary Outcome Measure

Change in Endogenous Thrombin Potential (ETP) [ Time Frame: at time 0 and 26 weeks ]

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