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LIPT - Liraglutide in Polycystic Ovary Syndrome (LIPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02073929
Recruitment Status : Completed
First Posted : February 28, 2014
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Jens Faber, Herlev Hospital

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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Cardiovascular Disease Drug: Liraglutide for 26 weeks Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Active
Liraglutide s.c. 1,8mg daily for 26 weeks
Drug: Liraglutide for 26 weeks
GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks

Placebo Comparator: Placebo
Placebo s.c. daily for 26 weeks
Drug: placebo
Placebo s.c. daily for 26 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  1. Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1 [ Time Frame: at time 0 and 26 weeks ]

Other Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • ...

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073929


Locations
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Denmark
Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital
Herlev, Denmark, 2730
Herlev Hospital, Dept of Gynecology
Herlev, Denmark, 2730
Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Jens Faber
Investigators
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Principal Investigator: Jens Faber, DSc Dept. of Medicine, Herlev Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jens Faber, Professor, DSc, Senior Hospital Physician, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02073929     History of Changes
Other Study ID Numbers: EudraCT nr 2013-003862-15
First Posted: February 28, 2014    Key Record Dates
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019
Last Verified: June 2015

Additional relevant MeSH terms:
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Syndrome
Cardiovascular Diseases
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists