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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02187250 |
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Date of registration:
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08/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome
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Scientific title:
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Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02187250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Andrej Janez, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Ljubljana |
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Key inclusion & exclusion criteria
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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
- history of pancreatitis
- 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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PCOS
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Obesity
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Intervention(s)
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Drug: roflumilast
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Drug: metformin
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Drug: liraglutide
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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.]
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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.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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