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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483299
• Other study ID #: LIRA COMBI
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2015
• Last updated: June 25, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• 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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• PCOS
• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin

• Glucophage tablets and Victoza

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	Change 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.	up to 12 weeks of clinical trial	No
Other	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.	up to 12 weeks of clinical trial	No
Other	Change in blood concentrations of LH (luteinizing hormone)	Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.	up to 12 weeks of clinical trial	No
Other	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.	up to 12 weeks of clinical trial	No
Other	Change in blood concentration of testosterone	Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.	up to 12 weeks of clinical trial	No
Other	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.	up to 12 weeks of clinical trial	No
Other	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.	up to 12 weeks of clinical trial	No
Other	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.	up to 12 weeks of clinical trial	No
Primary	Change in body weight		up to 12 weeks of clinical trial	No
Primary	The number of good responders to combined treatment regarding body weight		up to 12 weeks of clinical trial	No
Secondary	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.	up to 12 weeks of clinical trial	No
Secondary	Change in waist circumference	waist circumference was measured in centimeters.	up to 12 weeks of clinical trial	No