crossover randomized trial
DESIRE
Effects of Glucagon-Like Peptide-1 Analogs on Sexuality - a Randomized, Double-blind, Placebo-controlled Trial With Crossover Design
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg | lifestyle: none | 26 | 24 | |
| A2 | Placebo Placebo | lifestyle: none | 26 | 24 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Dulaglutide 1.5 mg subcutaneous once weekly A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age | median (years) | 24.5 | ||
| age | q1 (years) | 21.0 | ||
| age | q3 (years) | 29.0 | ||
| bmi | median (kg/m2) | 23.9 | ||
| bmi | q1 (kg/m2) | 22.2 | ||
| bmi | q3 (kg/m2) | 25.0 | ||
| hba1c | median (percent) | 5.1 | ||
| hba1c | q1 (percent) | 5.1 | ||
| hba1c | q3 (percent) | 5.3 | ||
| other male | n | 24 | ||
| other race mixed caucasian african | n | 1 | ||
| other race mixed caucasian african | percent | 4.2 | ||
| other race mixed caucasian hispanic | n | 2 | ||
| other race mixed caucasian hispanic | percent | 8.3 | ||
| sbp | mean (mmHg) | 118.5 | ||
| sbp | sd (mmHg) | 13.3 | ||
| white | n | 21 | ||
| white | percent | 87.5 |
Results
14 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 24 | not stated; completers; R0005106:Results | ||||
| A2 | events | 0 / 24 | not stated; completers; R0005106:Results |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 13 | not stated; randomized; R0005106:Results | ||||
| A2 | events | 0 / 13 | not stated; randomized; R0005106:Results |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 24 | not stated; completers; R0005106:Supplement Table S3 | ||||
| A2 | events | 0 / 24 | not stated; completers; R0005106:Supplement Table S3 |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 24 | not stated; completers; R0005106:Supplement Table S3 | ||||
| A2 | events | 0 / 24 | not stated; completers; R0005106:Supplement Table S3 |
Diarrhea (3 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 24 | not stated; completers; R0005106:Supplement Table S3 | ||||
| A1 vs A2 | rr | 2.8 | 0.4 to 17.4 | not stated; completers; R0005106:Supplement Table S3 | |||
| A2 | events | 1 / 24 | not stated; completers; R0005106:Supplement Table S3 |
Constipation (3 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 24 | not stated; completers; R0005106:Supplement Table S3 | ||||
| A1 vs A2 | rr | 4.3 | 0.8 to 24.2 | not stated; completers; R0005106:Supplement Table S3 | |||
| A2 | events | 1 / 24 | not stated; completers; R0005106:Supplement Table S3 |