Freundl 1998.
| Study characteristics | ||
| Methods | Trial design: randomised, double‐blind, comparative study | |
| Participants | Participants: 27 women were randomised and analysed. Mean age: group A: 35 ± 5 years, group P: 34.8 ± 5 years Inclusion criteria:
Exclusion criteria: not stated Setting: Germany Timing: not stated |
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| Interventions | Group A: received a combination of leuprorelin acetate depot with 20 mg ethinyloestradiol plus 0.15 mg desogestrel (n = 14) versus Group P: received leuprorelin acetate depot plus placebo (n = 13) |
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| Outcomes |
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| Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Contact with the author could not be established for further information; he unfortunately passed away. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Prospective double‐blind, randomised placebo‐controlled trial". No further details of method used to generate the randomisation sequence were provided. |
| Allocation concealment (selection bias) | Unclear risk | No details of method used to conceal allocation were provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, placebo‐controlled study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind, placebo‐controlled study |
| 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 |