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Completed

NCT Number: NCT02073929

LIPT - Liraglutide in Polycystic Ovary Syndrome

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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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cardiovascular Disease Cardiovascular Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital, Herlev, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • ...

Treatment and study plan

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

Primary outcomes

  1. Change in Endogenous Thrombin Potential (ETP)

    Time frame: at time 0 and 26 weeks

    Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min

Secondary outcomes

  1. Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1

    Time frame: at time 0 and 26 weeks

Other outcomes

  1. Change in Plasma Level of Adrenomedullin

    Time frame: at time 0 and 26 weeks

    measured in nmol/l

  2. Change in Plasma Level of Atrial Natriuretic Peptide (ANP)

    Time frame: at time 0 and 26 weeks

    measured in pmol/l

  3. Change in Plasma Level of Copeptin

    Time frame: at time 0 and 26 weeks

  4. Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)

    Time frame: at time 0 and 26 weeks

    percent change from baseline

  5. Change in Bleeding Pattern (Bleeding Ratio)

    Time frame: at time 0 and 26 weeks

    Ration between number of bleedings during 3 months before trial and last 3 months of trial

  6. Change in Percent Liver Fat Content

    Time frame: at time 0 and 26 weeks

    percent liver fat content

  7. Change in Body Composition (VAT)

    Time frame: at time 0 and 26 weeks

    cubic cm

  8. Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)

    Time frame: at time 0 and 26 weeks

    measured as ml

  9. Change in Serum Levels of Anti-Müllerian Hormone

    Time frame: at time 0 and 26 weeks

    measured as pmol/l

Sponsors and collaborators

Lead sponsor

Jens Faber

Other

Registry information

Official study title

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

Acronym: LIPT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 28, 2014
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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