| Methods |
Study Design: parallel, double‐blind, multicentre, placebo‐control, clinical trial
Randomisation: coded medication provided by manufacturer
Number of centres: 5
Duration of Trial: 12 weeks
Power Calculations: none
Number of women randomised: 119 to three treatment groups
Number of women analysed: 108
Intention‐to‐treat analysis: no
Losses to follow‐up/withdrawals from treatment: 11/119 = 9%. Breakdown: adverse events (5), lack of effect (3), other (3).
Compliance: not stated
Source of Funding: Novo Nordisk A/S, Bagsvaerd, Denmark |
| Participants |
Menopausal status: peri‐ and post‐menopausal
Age: mean 51 years, SD 4 Range = 45 to 61 years
Location: Norway Ethnicity: not stated
Source: gynaecological clinics
Inclusion Criteria: healthy women aged 45 to 61 years, moderate to severe vasomotor symptoms, at least 3 months amenorrhoea
Exclusion Criteria: abnormal bleeding, known or suspected breast or endometrial cancer, liver disease, venous thromboembolism, cardiac dysfunction, diabetes or thyroid disease, porphyria, current treatment with liver inducing medication and use of HRT of any steroids within the past 3 months
Confirmation of Ovarian Failure: not stated
Baseline Equality: equality reported for vasomotor symptoms, age, age at menopause, time since menopause, weight and previous HRT use
Baseline Symptoms: number of participants with vasomotor symptoms at baseline not stated but inclusion criteria required moderate‐severe hot flushes. The average severity score at baseline was 2.7 (0 to 3 scale). |
| Interventions |
Rx1 (E+P, CCT): 1mg E2 and 0.25mg NETARx2 (E+P, CCT): 1mg E2 and 0.5mg NETA (Activelle, Novo Nordisk)Rx3: placeboHRT and placebo preparations not reported.Co‐interventions: none reported |
| Outcomes |
1. Hot flush frequency2. Vasomotor severity (Kupperman's Index and Vasomotor subscale of Greene's Climacteric Score))3. Hot flush weekly weighted score4. Losses/withdrawals |
| Notes |
The author was contacted and kindly provided further data. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
