| Methods |
Study Design: parallel, double‐blind, multicentre, placebo‐controlled, randomised clinical trial
Randomisation: computer generated randomisation and treatment allocation codes
Number of Centres: 11
Duration of Trial: 4 months
Power Calculations: yes (based hot flush frequency outcome)
Number of women randomised: 219 into 5 treatment groups
Number of women analysed: 187 for hot flush frequency
Intention‐to‐treat analysis: yes, 'modified' ITT
Losses to follow‐up/withdrawals from treatment: not clear (31 women did not complete the study)
Compliance: assessed by medication return
Source of Funding: Parke‐Davis Pharmaceutical Research Division, Warner Lambert Company. |
| Participants |
Menopausal status: post‐menopausal
Age: mean 51.58 ± 0.58 years (mean ± SD) (range 41 to 65 years)
Location: USA
Ethnicity: Not provided when requested
Source: not clear if from a clinical or general population
Inclusion Criteria: ammenorrheic for at least one year, but not more than 5 years
Exclusion Criteria: history of any chronic disease, current vaginal bleeding or endometrial hyperplasia, any contraindications for HRT & use of HRT within 3 months prior to randomisation
Confirmation of Ovarian Failure: 6‐12 months amenorrhoea, E2 levels <= 25pg/mL, FSH >= 50 mIU/mL
Baseline Equality: matched for age, time since last menstrual period, hot flush frequency and smoking history
Baseline Symptoms: at least 10 hot flushes/week & an average of 48 hot flushes in the week prior to randomisation |
| Interventions |
Rx1 (E + P, low dose): ethinyl estradiol 1 µg + norethindrone acetate 0.2 mg
Rx2 (E + P, low dose): ethinyl estradiol 2.5 µg + norethindrone acetate 0.5 mg
Rx3 (E + P, medium dose): ethinyl estradiol 5 µg + norethindrone acetate 1 mg
Rx4 (E + P, high dose): ethinyl estradiol 10 µg + norethindrone acetate 1 mg
Rx5: placebo
The HRT and placebo preparations were identical in appearance
Co‐interventions: none reported |
| Outcomes |
1. Weekly hot flush frequency
2. Withdrawals from therapy
3. Adverse event frequency |
| Notes |
The author was contacted and supplied further information. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
