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PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02037672
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
PCOS Obesity Drug: metformin Drug: metformin and roflumilast Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome
Study Start Date : September 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014


Arm Intervention/treatment
Active Comparator: metformin
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
Other Name: Glucophage tablets

Active Comparator: metformin and roflumilast
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
Other Name: Glucophage tablets and Daxas 500 micrograms film-coated tablets




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037672


Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Andrej Janez, MD, PhD University Medical Centre Ljubljana

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Responsible Party: Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02037672     History of Changes
Other Study ID Numbers: DAXAS
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Andrej Janez, University Medical Centre Ljubljana:
PCOS
PDE-4 inhibitor
roflumilast
metformin
obesity

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Phosphodiesterase 4 Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action