Rotondi 2002.
| Study characteristics | ||
| Methods | Trial design: Randomised trial | |
| Participants | Participants: 81 women were randomised in a 2:1 ratio to leuprolide n = 54, or danazol n = 27. Mean age: mean age not provided; median age was 32 years (range 19‐41) Inclusion criteria:
Exclusion criteria: not stated Setting: Italy, fertility centre of the second University of Naples Timing: 1992 to 1999 |
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| Interventions | Leuprolide acetate 3.75 mg subcutaneously every 28 days, for 6 months versus Danazol 200 mg orally three times a day for 6 months |
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| Outcomes |
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| Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Excluded from previous version of this review as pain was not an outcome. Included in this review, but did not contribute any data |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly allocated". 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 | 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 | 3/54 women from leuprolide group and 5/27 from danazol group withdrew due to "adverse findings". |
| 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 |