PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02037672

Enrollment

Registered

2014-01-16

Start date

2013-09-30

Completion date

2014-01-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, PCOS

Keywords

PCOS, PDE-4 inhibitor, roflumilast, metformin, obesity

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.

Interventions

DRUGmetformin

DRUGmetformin and roflumilast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 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.
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 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.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026