Table 4.
Menstrual bleeding information and adverse reactions of special interest collected by participant questionnaire from consent up to 24 weeks
| Characteristic | Spironolactone (n=201) | Placebo (n=209) | Total (n=410) | p value |
|---|---|---|---|---|
| Irregular menstrual bleeding in the 12-24 week period*: | ||||
| Yes | 57 (32) | 61 (35) | 118 (33) | — |
| No/do not have periods | 123 (68) | 112 (65) | 235 (67) | 0.47 |
| Missing† | 21 (11) | 36 (17) | 57 (14) | — |
| At least one adverse reaction: | 128 (64) | 107 (51) | 235 (57) | 0.01 |
| Summary of adverse reactions‡: | ||||
| Abdominal pain | 9 (5) | 10 (5) | 19 (5) | 0.88 |
| Breast enlargement | 31 (15) | 25 (12) | 56 (14) | 0.31 |
| Diarrhoea | 7 (4) | 11 (5) | 18 (4) | 0.38 |
| Dizziness/vertigo/light headedness | 38 (19) | 26 (12) | 64 (16) | 0.07 |
| Drowsiness/sleepiness | 14 (7) | 18 (9) | 32 (8) | 0.53 |
| Fatigue/tiredness | 23 (11) | 29 (14) | 52 (13) | 0.46 |
| Headache | 41 (20) | 25 (12) | 66 (16) | 0.02 |
| Indigestion/heartburn/dyspepsia | 23 (11) | 17 (8) | 40 (10) | 0.26 |
| Nausea/feeling sick | 21 (11) | 16 (8) | 37 (10) | 0.32 |
| Polyuria (passing much more urine than usual) | 62 (31) | 52 (25) | 114 (28) | 0.18 |
| Reduced libido | 15 (8) | 11 (5) | 26 (6) | 0.36 |
| Tenderness of the breasts | 40 (20) | 37 (18) | 77 (19) | 0.57 |
| Tingling | 6 (3) | 10 (5) | 16 (4) | 0.35 |
| Vomiting/being sick | 4 (2) | 1 (1) | 5 (1) | 0.16 |
| Weight gain | 13 (7) | 17 (8) | 30 (7) | 0.52 |
| Other | 34 (17) | 22 (11) | 56 (14) | 0.06 |
Data are number of participants (percentage), unless otherwise specified and p values are from Pearson’s χ2 test.
*
Calculated using the no. of participants with non-missing information available.
†
Calculated as the no. of participants with this information missing (ie, did not provide period information at any of the time points) divided by those with period information available.
‡
Calculated using the no. of participants in the spironolactone/placebo group.