NCT02073929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 28, 2019

Completed
Last Updated

February 28, 2019

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

February 25, 2014

Results QC Date

June 20, 2017

Last Update Submit

February 27, 2019

Conditions

Polycystic Ovary SyndromeCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Endogenous Thrombin Potential (ETP)

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

    at time 0 and 26 weeks

Secondary Outcomes (1)

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

    at time 0 and 26 weeks

Other Outcomes (9)

  • Change in Plasma Level of Adrenomedullin

    at time 0 and 26 weeks

  • Change in Plasma Level of Atrial Natriuretic Peptide (ANP)

    at time 0 and 26 weeks

  • Change in Plasma Level of Copeptin

    at time 0 and 26 weeks

  • +6 more other outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Drug: Liraglutide for 26 weeks

Placebo

PLACEBO COMPARATOR

Placebo s.c. daily for 26 weeks

Drug: placebo

Interventions

Liraglutide for 26 weeksDRUG

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

Active
placeboDRUG

Placebo s.c. daily for 26 weeks

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Herlev, 2730, Denmark

Location

Herlev Hospital, Dept of Gynecology

Herlev, 2730, Denmark

Location

Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital

Herlev, DK-2730, Denmark

Location

Related Publications (1)

  • Frossing S, Nylander M, Chabanova E, Frystyk J, Holst JJ, Kistorp C, Skouby SO, Faber J. Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial. Diabetes Obes Metab. 2018 Jan;20(1):215-218. doi: 10.1111/dom.13053. Epub 2017 Aug 11.

    PMID: 28681988DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeCardiovascular Diseases

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Professor Jens Faber
Organization
Center of Endocrinology and Metabolism, Dept. of Internal Medicine, Herlev Gentofte Hospital, Denmark
jens.faber@regionh.dk
+4538689016

Study Officials

  • Jens Faber, DSc

    Dept. of Medicine, Herlev Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, DSc, Senior Hospital Physician

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 28, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 28, 2019

Results First Posted

February 28, 2019

Record last verified: 2015-06

Locations

DK(3)