PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

NCT02037672 | Completed Phase 4

• 1 other identifier: DAXAS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

• 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.

Other Outcomes (8)

• 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.

• 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.

• 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.

Study Arms (2)

metformin

ACTIVE COMPARATOR

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.

Drug: metformin

metformin and roflumilast

ACTIVE COMPARATOR

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.

Drug: metformin and roflumilast

Interventions

metformin DRUG

Also known as: Glucophage tablets

metformin

metformin and roflumilast DRUG

Also known as: Glucophage tablets and Daxas 500 micrograms film-coated tablets

metformin and roflumilast

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old to menopause
• polycystic ovary syndrome (NICHD criteria)
• BMI of 30 kg/m² or higher

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Obesity

Interventions

Metformin; Roflumilast

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Andrej Janez, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD, PhD

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

SL (1)