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 |