Strowitzki 2012.
Study characteristics | ||
Methods | Trial design: The study was a multi‐centre, randomised, open‐label, parallel‐group, non‐inferiority comparison. | |
Participants | Participants: 252 women were randomised; 229 women were analysed. Mean age: 18–45 years Inclusion criteria:
Exclusion criteria:
Setting: Germany Timing: not stated |
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Interventions | Dienogest (DNG) 2 mg/day orally (n = 124) versus Intramuscular leuprolide acetate 3.75 mg depot every 4 weeks (n = 128) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: No. "Efficacy analyses were based on the per‐protocol set (PPS), which included all randomized patients without major protocol deviations (a 'conservative' strategy appropriate for non‐inferiority studies)". Sample size calculation: yes Funding: Funding for the study was provided by Bayer HealthCare. J.M., C.G., T.F., and C.S. are full‐time employees of Bayer HealthCare. Editorial support funded by Bayer HealthCare was provided by PAREXEL. This editorial support consisted of the preparation of manuscript drafts based on detailed author guidance. Authors contacted; awaiting response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomized (1:1 ratio)". No further details of method used to generate the randomisation sequence were provided. |
Allocation concealment (selection bias) | Unclear risk | weo details of method used to conceal allocation are provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided of blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall, 109/124 (87.9%) women in the DNG group and 120/128 (93.8%) women in the LA group completed the study. |
Selective reporting (reporting bias) | Low risk | The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | No other risk of bias detected |