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Completed

NCT Number: NCT02483299

Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome

The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.

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Key information

Conditions

PCOS Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

metformin

Drug

Other names: Glucophage tablets

Glucophage tablets and Victoza

Drug

Other names: Glucophage tablets and Victoza 6 mg/ml solution for injection in pre-filled pen

Primary outcomes

  1. Change in body weight

    Time frame: up to 12 weeks of clinical trial

  2. The number of good responders to combined treatment regarding body weight

    Time frame: up to 12 weeks of clinical trial

Secondary outcomes

  1. Change in body mass index (BMI).

    Time frame: up to 12 weeks of clinical trial

    Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.

  2. Change in waist circumference

    Time frame: up to 12 weeks of clinical trial

    waist circumference was measured in centimeters.

Other outcomes

  1. Change in fasting concentrations of glucose

    Time frame: up to 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. Change in fasting concentration of insulin

    Time frame: up to 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. Change in blood concentrations of LH (luteinizing hormone)

    Time frame: up to 12 weeks of clinical trial

    Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.

  4. Change in blood concentrations of FSH (follicle-stimulating hormone)

    Time frame: up to 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. Change in blood concentration of testosterone

    Time frame: up to 12 weeks of clinical trial

    Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.

  6. Change in blood concentration in androstenedione

    Time frame: up to 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. Change in blood concentrations of SHBG (sex hormone-binding globulin)

    Time frame: up to 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. Change in blood concentration of DHEAS (dehydroepiandrosterone sulfate)

    Time frame: up to 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2015
Registry last updated
Jun 26, 2015

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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