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

Osmanağaoğlu 2006.

Methods Randomised controlled trial
Participants 165 naturally postmenopausal women; absence of menstruation > 1 year; FSH ≥ 30 IU/L; not undergone any gynaecological operation; no absolute contraindication for HT. Mean age 50 years
Interventions
  • Tibolone 2.5 mg/d

  • Oestradiol valerate 2 mg plus dienogest 2 mg/d


Administered for 6 months
Outcomes Lubrication and pain during sexual intercourse as score at baseline and at post treatment
Notes Only 107 women were considered in the analyses (excluding women assigned to "no treatment")
Even if not specified in the protocol, lubrication has been evaluated as a measure of vaginal dryness
Timing: unclear
Location: Turkey?
Multi‐centre: not specified
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Study authors declare that the study is single‐blind (participant), but in some cases, women were given doctor samples from drug companies
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcomes were evaluated through a self‐administered questionnaire, but it is unclear whether participating women were blind
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 7/165 participants without follow‐up data
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest Low risk Study authors declare that they did not receive external funding and that they do not have conflicts of interest