Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug |
|
| |
| metformin and roflumilast |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The other outcomes was changes in fasting concentrations of glucose. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L. | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrej Janez, MD, PhD | University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana | Ljubljana | 1000 | Slovenia |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| C424423 | Roflumilast |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| The secondary outcome was change in waist circumference. |
Patient's waist circumference was measured in centimeters. |
| Patient's waist circumference was measured at the basepoint and every four weeks during 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. |
| 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 blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L. | 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 FSH (follicle-stimulating hormone). | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L. | 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 concentration of testosterone. | Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L. | 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 concentration in androstenedione. | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L. | 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 SHBG (sex hormone-binding globulin). | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L. | 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 concentration of DHEAS (dehydroepiandrosterone sulfate). | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |