Table 1.
Demographics and baseline characteristics of the 28 women who completed the trial (per-protocol set)
| Group 1: allocated to MLE4901 and then placebo (n=16) | Group 2: allocated to placebo and then MLE4901 (n=12) | ||
|---|---|---|---|
| Age (years, range) | 56 (50–62) | 54 (49–61) | |
| Ethnicity | |||
| White British | 8 (50%) | 9 (75%) | |
| White European | 2 (13%) | 0 | |
| White other | 1 (6%) | 0 | |
| White unspecified | 0 | 1 (8%) | |
| Asian, Pakistani | 1 (6%) | 0 | |
| Black Caribbean | 3 (19%) | 2 (17%) | |
| Mixed white and black Caribbean | 1 (6%) | 0 | |
| Body-mass index (kg/m2) | 27·0 (4·2) | 24·7 (3·7) | |
| Blood pressure (mm Hg) | |||
| Normotensive | 15 (94%) | 10 (83%) | |
| Hypertensive | 1 (6%) | 2 (17%) | |
| Body temperature at screening appointment (°C) | 36·4 (0·4) | 36·7 (0·4) | |
| Duration of oligomenorrhoea (months) | 135 (96) | 96 (66) | |
| Duration since last menstrual period (months) | 119 (94) | 77 (63) | |
| Duration since hot flushes (months) | 79 (47) | 74 (65) | |
| Menarche (age, years) | 13 (1) | 13 (2) | |
| Regular menstrual cycles in adulthood | |||
| Regular | 13 (81%) | 10 (83%) | |
| Irregular | 3 (19%) | 2 (17%) | |
| Gravida | 2 (2) | 3 (2) | |
| Parity | 1 (1) | 2 (2) | |
| Hysterectomy | |||
| No | 11 (69%) | 12 (100%) | |
| Hysterectomy | 4 (25%) | 0 | |
| Hysterectomy and bilateral salpingo-oophorectomy | 1 (6%) | 0 | |
| History of hormone replacement therapy use | |||
| Yes | 5 (31%) | 1 (8%) | |
| No | 11 (69%) | 11 (92%) | |
| History of Mirena coil use | |||
| Yes | 2 (12%) | 2 (17%) | |
| No | 14 (88%) | 10 (83%) | |
| History of herbal remedy use of any type | |||
| Yes | 11 (69%) | 6 (50%) | |
| No | 5 (31%) | 6 (50%) | |
| Smoking status | |||
| Never smoked | 13 (82%) | 5 (42%) | |
| Ex-smoker | 1 (6%) | 4 (33%) | |
| Current smoker | 2 (12%) | 3 (25%) | |
| Alcohol consumption | |||
| ≤14 units per week | 16 (100%) | 12 (100%) | |
| >14 units per week | 0 | 0 | |
| Luteinising hormone at screening appointment (IU/L) | 31·7 (11·8) | 33·2 (7·3) | |
| Follicle-stimulating hormone at screening appointment (IU/L) | 70·0 (20·5) | 74·9 (23·1) | |
| Progesterone at screening appointment (nmol/L) | 0·9 (0·0) | 0·9 (0·0) | |
| Oestradiol at screening appointment (pmol/L) | 69 (0) | 69 (0) | |
| Prolactin at screening appointment (mU/L) | 166 (47) | 167 (69) | |
| Androstenedione at screening appointment (nmol/L) | 1·5 (0·8) | 1·9 (1·0) | |
| Dehydroepiandrosterone at screening appointment (μmol/L) | 2·8 (2·1) | 3·1 (2·0) | |
| Sex hormone binding globulin at screening appointment (nmol/L) | 61 (30) | 56 (19) | |
| Extracted testosterone at screening appointment (nmol/L) | 0·7 (0·4) | 0·8 (0·3) | |
Data are mean (SD) or n (%), unless stated otherwise.