parallel randomized trial
NCT02187250
Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Metformin Metformin 1000 mg twice daily | lifestyle: standard | 13 | ||
| A2 | Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg daily | lifestyle: standard | 14 | ||
| A3 | Roflumilast Roflumilast 500 ug daily | lifestyle: standard | 14 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Metformin A1 | Liraglutide 1.2 mg subcutaneous once daily A2 | Roflumilast A3 | Whole trial ALL |
|---|---|---|---|---|---|
| age | mean (years) | 30.7 | |||
| age | sd (years) | 7.9 | |||
| bmi | mean (kg/m2) | 39.4 | 36.7 | 39.9 | |
| bmi | sd (kg/m2) | 6.9 | 5.6 | 5.4 | |
| female | n | 45 | |||
| waist | mean (cm) | 120.5 | 115.7 | 123.0 | |
| waist | sd (cm) | 14.5 | 12.5 | 15.9 | |
| weight | mean (kg) | 108.3 | 102.8 | 111.1 | |
| weight | sd (kg) | 17.0 | 16.3 | 16.1 |
Analyses this trial contributes to
Results
11 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / | not stated; other; R0023497:Results | ||||
| A2 | events | 1 / | not stated; other; R0023497:Results | ||||
| A3 | events | 1 / | not stated; other; R0023497:Results |
Nausea (3 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 14 | not stated; other; R0023497:Results | ||||
| A2 | events | 4 / 14 | not stated; other; R0023497:Results | ||||
| A3 | events | 5 / 14 | not stated; other; nausea and diarrhea; R0023497:Results |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 14 | not stated; other; R0023497:Results | ||||
| A2 | events | 1 / 14 | not stated; other; R0023497:Results |
Constipation (1 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 2 / 14 | not stated; other; R0023497:Results |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / | not stated; other; diarrhea; R0023497:Results | ||||
| A2 | events | 1 / | not stated; other; nausea; R0023497:Results |