PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT02187250

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to determine whether monotherapy treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who have not been treated before. The investigators anticipated greater changes in body weight in patients on roflumilast treatment than in liraglutide or metformin.

Condition or Disease	Intervention/Treatment	Phase
PCOS Obesity	Drug: metformin Drug: liraglutide Drug: roflumilast	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metformin In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 2x1000 mg BID per os.	Drug: metformin Other Names: Glucophage tablets
Active Comparator: liraglutide In the liraglutide group liraglutide was initiated at a dose of 0,6mg sc once per day for one week and increased to 1,2mg sc one per day.	Drug: liraglutide Other Names: Victoza injection
Active Comparator: roflumilast In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os.	Drug: roflumilast Other Names: Daxas 500 micrograms film-coated tablets

Arm

Intervention/Treatment

Active Comparator: metformin

In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 2x1000 mg BID per os.

Drug: metformin

Other Names:

Glucophage tablets

Active Comparator: liraglutide

In the liraglutide group liraglutide was initiated at a dose of 0,6mg sc once per day for one week and increased to 1,2mg sc one per day.

Drug: liraglutide

Other Names:

Victoza injection

Active Comparator: roflumilast

In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os.

Drug: roflumilast

Other Names:

Daxas 500 micrograms film-coated tablets

Outcome Measures

Primary Outcome Measures

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.]
The patient's body weight was measured in kilograms.

Secondary Outcome Measures

The secondary outcome was change in body mass index (BMI). [Patient's body weight were measured at the basepoint 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 Outcome Measures

The other outcomes was changes in fasting concentrations of glucose. [Patient's fasting blood was drawn at the base point and at the endpoint of 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 fasting concentration of insulin. [Patient's fasting blood was drawn at the base point and at the endpoint of 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 base point and at the endpoint of 12 weeks of clinical trial.]
Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.
Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone). [Patient's fasting blood was drawn at the base point and at the endpoint of 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 base point and at the endpoint of 12 weeks of clinical trial.]
Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.
Other outcome was change in blood concentration in androstenedione. [Patient's fasting blood was drawn at the base point and at the endpoint of 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 blood concentrations of SHBG (sex hormone-binding globulin). [Patient's fasting blood was drawn at the base point and at the endpoint of 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 base point and at the endpoint of 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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