Nijland 2009.

Methods	Randomised controlled trial
Participants	403 healthy women who had undergone natural menopause, with an intact uterus and with female sexual dysfunction associated with sexuality‐related personal distress. Mean age 55.8 years
Interventions	Tibolone 2.5 mg/d Estradiol (50 microgr) + norethisterone acetate (140 microgr) in the form of a transdermal patch Administered for 24 weeks
Outcomes	Unscheduled bleeding, cerebrovascular events, mortality from any cause
Notes	Timing: June 2004 to November 2005 Location: Europa, USA, Australia Multi‐centre: 29 centres
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised automatic interactive voice response system was used
Allocation concealment (selection bias)	Low risk	Computerised automatic interactive voice response system was used, and treatment assignment was stored electronically
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐dummy fashion
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors blinded to treatment assignment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	6% to 10% were not analysed for unspecified protocol violations
Selective reporting (reporting bias)	Low risk	Some outcomes indicated in the protocol (vaginal bleeding and spotting rate) were assessed and reported in the study publication. Those not reported were of no interest for this review. Additional information on cerebrovascular events and mortality from any cause was available in the study publication and was considered for this review
Conflict of interest	High risk	Study sponsored by the drug manufacturer, and some study authors were employees of the drug firm