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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02037672
Other study ID # DAXAS
Secondary ID
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


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
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