Polycystic Ovary Syndrome and Liraglutide

Short-term Liraglutide Treatment in Obese Women With Polycystic Ovary Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899430

Enrollment

Registered

2013-07-15

Start date

2011-11-30

Completion date

2013-04-30

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, PCOS

Keywords

PCOS, obesity, GLP-1 receptor agonist, liraglutide, metformin

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.

Interventions

DRUGliraglutide

DRUGmetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The main outcome was change in body weight.	Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Secondary

Measure	Time frame	Description
The secondary outcome was change in body mass index (BMI)	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.
The secondary outcome was change in waist circumference.	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

Measure	Time frame	Description
Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).	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.
Other outcome was change in blood concentration of testosterone.	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.
The other outcomes was changes changes in fasting concentrations of glucose.	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.
Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).	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.
Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate)	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.
Otehr outcome was change in blood concentration in androstenedione.	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.
Other outcome was change in fasting concentration of insulin.	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.
Other outcome was change in blood concentrations of LH (luteinizing hormone).	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.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026