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Completed

NCT Number: NCT02037672

PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Other names: Glucophage tablets

metformin and roflumilast

Drug

Other names: Glucophage tablets and Daxas 500 micrograms film-coated tablets

Primary outcomes

  1. The main outcome was change in body weight.

    Time frame: 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 outcomes

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

    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.

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

  2. The secondary outcome was change in waist circumference.

    Time frame: 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 outcomes

  1. The other outcomes was changes in fasting concentrations of glucose.

    Time frame: 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.

  2. Other outcome was change in fasting concentration of insulin.

    Time frame: 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.

  3. Other outcome was change in blood concentrations of LH (luteinizing hormone).

    Time frame: 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.

  4. Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).

    Time frame: 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.

  5. Other outcome was change in blood concentration of testosterone.

    Time frame: 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.

  6. Other outcome was change in blood concentration in androstenedione.

    Time frame: 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.

  7. Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).

    Time frame: 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.

  8. Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 16, 2014
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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