PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

Obesity Clinical Trial

Official title:

Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037672
• Other study ID #: DAXAS
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2014
• Last updated: January 21, 2014
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• 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 phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. The investigators anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• 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:

• depression

• type 1 or type 2 diabetes mellitus

• history of carcinoma

• 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

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

• metformin and roflumilast

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 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 base point and at the endpoint of 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 base point and at the endpoint of 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. Concentration of LH was measured in U/L.	Patient's fasting blood was drawn at the base point and at the endpoint of 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 base point and at the endpoint of 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 base point and at the endpoint of 12 weeks of clinical trial.	No
Other	Other 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 base point and at the endpoint of 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 base point and at the endpoint of 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 base point and at the endpoint of 12 weeks of clinical trial.	No
Primary	The main outcome was change in body weight.	The patient's body weight was measured in kilograms.	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 basepoint 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