Cirkel 1995.
| Study characteristics | ||
| Methods | Trial design: "randomised controlled comparative clinical study" | |
| Participants | Participants: 60 women eligible; 60 were randomised and 55 were analysed. Mean age: 30 ± 0.5 (triptorelin depot) and 30 ± 0.8 (danazol) Inclusion criteria:
Exclusion criteria:
Setting: Germany Timing: February 1989 and December 1990 |
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| Interventions | Triptorelin 3.75 mg IM depot every 28 days for 24 weeks (n = 30) versus Danazol 200 mg three times a day (600 mg/day) PO for 24 weeks (n = 25) | |
| Outcomes |
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| Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Authors contacted and awaiting response regarding methods |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients were allocated to a computer‐generated randomisation list. |
| Allocation concealment (selection bias) | Unclear risk | No further details of method used to conceal allocation were provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label trial as blinding of study personnel and participants would not have been possible due to nature of the intervention. |
| 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 | High risk | Five women assigned to danazol could not be included further: three patients refused to fulfill the protocol after randomisation and two others conceived spontaneously before starting medication. Twenty‐four weeks after the end of endocrine therapy, 20 women (12/30 in the triptorelin and 8/25 in the danazol group) had an additional follow‐up for evaluation of clinical symptomatology as well as laboratory parameters. |
| 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 |