Odukoya 1995.
Study characteristics | ||
Methods | Trial design: Randomised study | |
Participants | Participants: 21 women were randomised and analysed. Mean age: 33 ± 5 years Inclusion criteria:
Exclusion criteria: not stated Setting: United Kingdom Timing: not stated |
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Interventions | Leuprolide acetate 3.75 SC monthly for 3 months (n = 10) versus Danazol 400 mg daily PO for 3 months (n = 11) | |
Outcomes |
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Notes | Intention‐to‐treat analysis: Yes Sample size calculation: not stated Funding: not stated Note previous version: Authors contacted regarding methods (blinding) and SD data; awaiting response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was "computer generated". No further details of method used to generate the randomisation sequence were provided. |
Allocation concealment (selection bias) | Low risk | "concealed in an envelope only opened at commencement of treatment". No further details of method used to conceal allocation were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided of blinding of participants or trial 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 | No losses to follow‐up |
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 |