| Methods |
Open, parallel‐group, single‐blinded comparative trial with active control, randomised in the proportions 2:1
Number of centres: 9
Number of women randomised: n = 165
Number of women analysed: n = 146
Number of withdrawals: n = 19; 8 women withdrew before 12 weeks treatment (6 in the ring group and 2 in the pessary group). In 2 cases the ring fell out, and in 4 the ring was taken out due to adverse effects (fever, pain, pruritus, urticaria, impaired asthma, and too short vagina). In the pessary group 1 woman was lost and 1 refused to take pessaries due to burning mucosa and disturbed sleep. 1 woman from the ring group was excluded from per protocol analysis because of wrong randomisation; 4 excluded due to loss of ring before visit 3. In pessary group; 6 excluded from per protocol analysis at visit 3; one had taken hormonal treatment after visit 2, 5 had forgotten to take pessaries before visit 3, 3 women were excluded from per protocol analysis at visit 2, 2 had not taken all pessaries prescribed, and one taken pessaries without removing plastic wrapping.
Power calculation for sample size performed and analysis by ITT |
| Participants |
Inclusion criteria: postmenopausal women at least 2 years after spontaneous or surgical (bilateral oophorectomy) menopause, complaining of oestrogen deficiency symptoms of atrophic vaginitis, signs of atrophic vaginal mucosa
Age: 45‐80 years (mean 59)
Source of participants: centres
Exclusion criteria: oestrogen‐dependant neoplasia, abnormal vaginal bleeding of unknown origin, acute or chronic liver disease, acute intermittent porphyria, thromboembolic disease, sex hormone treatment during preceding 3 months, uterovaginal prolapse (grade II to III) and significant bacteruria
Location: outpatients; 4 in Sweden, 3 in Finland and 2 in Denmark |
| Interventions |
Treatment: silicone rubber vaginal ring (silastic) containing 2 mg of micronised 17β‐oestradiol releasing 6.5 to 9.5 mcg per 24 hours over a 3‐month period
Control: vaginal pessaries (Ovesterin) 0.5 mg estriol daily for 3 weeks. weeks 4‐12; 1 pessary twice weekly
Duration: 3 months |
| Outcomes |
Cured/improved subjects' symptoms, physician assessment of mucosa, maturation value, vaginal pH, adverse events, withdrawals, adherence
administration form, sexual discomfort, no other discomfort |
| 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) |
High risk |
Open label trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Single‐blinded trial but some of the outcomes were participant‐assessed |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Data were analysed on the basis of ITT |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a conclusive judgement |
| Other bias |
Unclear risk |
Treatment groups were balanced at baseline |
