Doren 1999.
Methods | Randomised double‐blind placebo‐controlled study | |
Participants | 98 healthy postmenopausal women, with intact uterus (mean age 56 years), mean BMI 25 kg/m2, mean time since menopause 6 years | |
Interventions |
For 12 months |
|
Outcomes | Unscheduled bleeding | |
Notes | Timing: unclear Location: Netherlands; single centre Hot flashes and sleeplessness reported as adverse events, each by 1 participant |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Describe: no details on randomisation |
Allocation concealment (selection bias) | Unclear risk | Describe: no details given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Describe: participants blinded but no details on personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Describe: participants recorded bleeding episodes in a diary |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Describe: reasons for withdrawal explained |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Conflict of interest | High risk | Describe: study sponsored by manufacturer of tibolone; employer among study authors |