Clinical trial NCT02037672: PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome
Official title: Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Obesity
Keywords: PCOS
PDE-4 inhibitor
roflumilast
metformin
obesity
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The main outcome was change in body weight.
timeFrame: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.
Secondary outcomes:
measure: The secondary outcome was change in body mass index (BMI).
timeFrame: 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.
measure: The secondary outcome was change in waist circumference.
timeFrame: Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.
Other outcomes:
measure: The other outcomes was changes in fasting concentrations of glucose.
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Other outcome was change in fasting concentration of insulin.
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Other outcome was change in blood concentrations of LH (luteinizing hormone).
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Other outcome was change in blood concentration of testosterone.
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Other outcome was change in blood concentration in androstenedione.
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate).
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Andrej Janez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: