Polycystic Ovary Syndrome and Liraglutide

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899430
• Other study ID #: 20120047
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2013
• Last updated: July 10, 2013
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• PCOS
• Polycystic Ovary Syndrome

Intervention

Drug:
• liraglutide

• metformin

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The other outcomes was changes changes in fasting concentrations of glucose.	Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.	No
Other	Other outcome was change in fasting concentration of insulin.	Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.	No
Other	Other outcome was change in blood concentrations of LH (luteinizing hormone).	Patient's blood was drawn between 8 and 9 a.m. Comncetration of LH was measured in U/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial	No
Other	Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial	No
Other	Other outcome was change in blood concentration of testosterone.	Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.	No
Other	Otehr outcome was change in blood concentration in androstenedione.	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial	No
Other	Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial	No
Other	Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate)	Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L.	Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial.	No
Primary	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.	No
Secondary	The secondary outcome was change in body mass index (BMI)	Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.	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.	No
Secondary	The secondary outcome was change in waist circumference.	Patient's waist circumference was measured in centimeters.	Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.	No