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. 2016 Oct 12;2016(10):CD008536. doi: 10.1002/14651858.CD008536.pub3

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
  • Tibolone 2.5 mg/d

  • 17beta‐oestradiol + NETA (2 + 1 mg/d)


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