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Polycystic Ovary Syndrome and Liraglutide

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ClinicalTrials.gov Identifier: NCT01899430
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

Brief Summary:
The purpose of this study was to determine whether liraglutide is more effective than metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide than in those treated with metformin.

Condition or disease Intervention/treatment Phase
PCOS Obesity Drug: liraglutide Drug: metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-term Liraglutide Treatment in Obese Women With Polycystic Ovary Syndrome
Study Start Date : November 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: metformin
In the MET group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os.
Drug: metformin
Other Name: Glucophage tablets

Experimental: liraglutide
In the LIRA group liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week.
Drug: liraglutide
Other Name: Victoza 6 mg/ml solution for injection in pre-filled pen




Primary Outcome Measures :
  1. The main outcome was change in body weight. [ Time Frame: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial. ]

Secondary Outcome Measures :
  1. The secondary outcome was change in body mass index (BMI) [ Time Frame: Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint. ]
    Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.

  2. The secondary outcome was change in waist circumference. [ Time Frame: Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial. ]
    Patient's waist circumference was measured in centimeters.


Other Outcome Measures:
  1. The other outcomes was changes changes in fasting concentrations of glucose. [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial. ]
    Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

  2. Other outcome was change in fasting concentration of insulin. [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial. ]
    Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.

  3. Other outcome was change in blood concentrations of LH (luteinizing hormone). [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial ]
    Patient's blood was drawn between 8 and 9 a.m. Comncetration of LH was measured in U/L.

  4. Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone). [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial ]
    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L.

  5. Other outcome was change in blood concentration of testosterone. [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial. ]
    Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.

  6. Otehr outcome was change in blood concentration in androstenedione. [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial ]
    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.

  7. Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin). [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial ]
    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.

  8. Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate) [ Time Frame: Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial. ]
    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old to menopause
  • polycystic ovary syndrome (NICHD criteria)
  • BMI of 30 kg/m² or higher

Exclusion Criteria:

  • type 1 or type 2 diabetes mellitus
  • history of carcinoma
  • Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
  • personal or family history of MEN 2
  • significant cardiovascular, kidney or hepatic disease
  • the use of medications known or suspected to affect reproductive or metabolic functions
  • the use of statins, within 90 days prior to study entry

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): NCT01899430


Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Andrej Janez, MD, PhD University Medical Centre Ljubljana

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Responsible Party: Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01899430     History of Changes
Other Study ID Numbers: 20120047
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Keywords provided by Andrej Janez, University Medical Centre Ljubljana:
PCOS
obesity
GLP-1 receptor agonist
liraglutide
metformin

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