Nathorst‐Böös 1997.

Methods	Randomised controlled trial
Participants	437 healthy women, ≥ 1 year postmenopausal or had been using hormone replacement therapy (HRT) > 2 years. Women were older than 53 years at entry and had been without HRT for longer than 1 month. All had had hot flushes and sweating, had a body mass index < 30 and had an intact uterus
Interventions	Tibolone 2.5 mg/d 17β‐oestradiol 2 mg/d and norethisterone acetate 1 mg/d Administered for 12 months
Outcomes	Vaginal dryness and pain during sexual intercourse as score at baseline and as differences between pretreatment and post‐treatment
Notes	Timing: unclear Location : Denmark, Norway, Sweden Unclear number of sites, but locations in 3 Scandinavian countries
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list and codes
Allocation concealment (selection bias)	Low risk	Sealed envelope containing the code
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind, double‐dummy not specified
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Subjective outcomes (McCoy’s Sex Scale Questionnaire) that may be subject to bias in the absence of double‐blind (double‐dummy not specified).
Incomplete outcome data (attrition bias) All outcomes	High risk	264/437 (60.4%) completed all assessments (baseline, at 24 and 48 weeks)
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	Unclear risk	Unclear risk: not specified