Morais‐Socorro 2012.

Methods	Randomised double‐blind placebo‐controlled trial
Participants	65 women between 40 and 55 years of age, with menstrual irregularity during the previous 6 months but fewer than 12 months of amenorrhoea, presence of a uterus without anomalies in an initial vaginal ultrasonography evaluation and an endometrial thickness measurement ≤ 10 mm; Kupperman Menopausal Index (KMI) score ≥ 14 points. Mean age 48.5 years
Interventions	Tibolone 2.5 mg/d, placebo for 12 weeks
Outcomes	Greene scale (vasomotor symptoms), Kupperman Index, vaginal bleeding‐spotting (based on number of days of uninterrupted bleeding and number of pads or tampons/d required)
Notes	Trial location: Brazil (unclear if multi‐centre) Timing: unclear
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Study authors declare that this is a double‐blind trial but do not provide information on blinding methods
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	High risk	10% and 14% dropout in tibolone and placebo arms, respectively
Selective reporting (reporting bias)	Low risk	Some of the outcomes indicated in the protocol (Kupperman Index, Greene scale) were assessed and reported in the study publication. Those not reported were of no interest for this review. Additional information on vaginal bleeding‐spotting was available in the study publication and was considered for this review
Conflict of interest	Low risk	Supported by grant from the CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico ‐ "National Counsel of Technological and Scientific Development")