| Methods |
Method of randomisation: not stated
Double‐blind, parallel design, placebo controlled
Number of participants: randomised: n = 84
Number of participants analysed: n = 67 (33 in ring group and 34 in placebo group)
Number of withdrawals: 4 participants excluded due to protocol violation (3 in ring group and 1 in placebo group). 13 withdrawals due to participant request (6 in ring group and 4 placebo group), adverse events (1 case of profuse eczema in placebo group), lack of efficacy (1 case in placebo group) and abandonment (1 case in oestradiol group)
No power calculation and no ITT analysis
Source of funding: Pharmacia and Upjohn |
| Participants |
Inclusion and exclusion criteria as per study 1
Location: Germany |
| Interventions |
Treatment: oestradiol‐releasing silicone ring (Estring) per study 1
Control: placebo ring |
| Outcomes |
Maturation value, vaginal pH, endometrial thickness, freedom of symptoms (dyspareunia, pallor, petechiae, friability, vaginal dryness) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not reported |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias) |
Low risk |
Double‐blinded trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Some outcomes were self‐assessed but unclear whether other outcome assessors were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Data analysed on the basis of ITT |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a conclusive judgement |
| Other bias |
Unclear risk |
Insufficient information to make a conclusive judgement |
