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PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

Primary Purpose

PCOS, Obesity

Status

Completed

Phase

Phase 4

Locations

Slovenia

Study Type

Interventional

Intervention

metformin

metformin and roflumilast

About this trial

This is an interventional treatment trial for PCOS focused on measuring PCOS, PDE-4 inhibitor, roflumilast, metformin, obesity

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

University Medical Center Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

metformin

metformin and roflumilast

Arm Description

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 1000 mg BID per os.

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 1000 mg BID per os. At the same time roflumilast was initiated at a dose of 500 mg BID per os.

Outcomes

Primary Outcome Measures

The main outcome was change in body weight.

The patient's body weight was measured in kilograms.

Secondary Outcome Measures

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.

The secondary outcome was change in waist circumference.

Patient's waist circumference was measured in centimeters.

Full Information

NCT ID

NCT02037672

First Posted

January 14, 2014

Last Updated

January 21, 2014

Sponsor

University Medical Centre Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT02037672

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PCOS, Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

metformin

Arm Type

Active Comparator

Arm Description

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 1000 mg BID per os.

Arm Title

metformin and roflumilast

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

metformin

Other Intervention Name(s)

Glucophage tablets

Intervention Type

Drug

Intervention Name(s)

metformin and roflumilast

Other Intervention Name(s)

Glucophage tablets and Daxas 500 micrograms film-coated tablets

Primary Outcome Measure Information:

Title

The main outcome was change in body weight.

Description

The patient's body weight was measured in kilograms.

Time Frame

Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Secondary Outcome Measure Information:

Title

The secondary outcome was change in body mass index (BMI).

Description

Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.

Time Frame

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.

Title

The secondary outcome was change in waist circumference.

Description

Patient's waist circumference was measured in centimeters.

Time Frame

Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

Other Pre-specified Outcome Measures:

Title

The other outcomes was changes in fasting concentrations of glucose.

Description

Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

Time Frame