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. 2012 Aug 15;2012(8):CD000402. doi: 10.1002/14651858.CD000402.pub4

Byrjalsen 1992.

Methods Randomisation: method not stated 
 Single‐blind, parallel‐group, placebo‐controlled, single centre 
 Number of women randomised: 73 
 Number of women analysed: 66 
 Number of early withdrawals: 7 (3 because of vaginal bleeding, 1 because of oedema of the legs, 2 because of lack of time, 1 because of illness unrelated to study)
Participants Country: Denmark 
 Inclusion criteria: healthy postmenopausal women aged 45 to 54 years who had experience natural menopause 9 to 40 months previously 
 Exclusion criteria: diseases or concomitant medications known to influence study measurements
Interventions Sequential vs sequential vs placebo
(A) 2 mg EV days 1 to 21 + 10 mg MPA daily days 12 to 21 
 (B) 1.5 mg E2 days 1 to 24 + 150 µg DG days 13 to 24 
 (C) placebo 
 Duration: 2 years
Outcomes Mean duration of withdrawal bleed, amenorrhoea, endometrial biopsy
Power calculation described No
Analysis by Intention to Treat No
Notes ‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding (performance bias and detection bias) 
 All outcomes Low risk Single blind
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 73 women were randomised to 3 groups. Biopsies at the end of the study on 56 women (77% of those randomised)
Other bias Low risk 3 groups balanced at baseline