Table I.
Patient characteristics at recruitment, by randomized group
| CDB-2914 (n = 69) | Placebo (n = 67) | |
|---|---|---|
| Age (years) at LNG-IUS insertion—Mean (SD) | 36.9 (6.5) | 35.8 (7.0) |
| Reported length (days) of most recent menstrual period—Mean (SD) | 5.9 (1.7) | 5.6 (1.5) |
| Length (days) of diary-screened menstrual cycle—Mean (SD) | 28.8 (4.7) | 28.0 (4.1) |
| Days prior to LNG-IUS insertion that most recent menstrual period started—Median (Q1, Q3) | 12 (7, 19) | 15 (10, 21) |
| IUD in situ at insertion visit—N (%) | 5 (7) | 9 (13) |
| Current smoker—N (%) | 13 (19) | 11 (16) |
| Employment—N (%) | ||
| Full-time | 30 (43) | 32 (48) |
| Part-time | 28 (41) | 26 (39) |
| No job | 11 (16) | 8 (12) |
| Number of deliveries—N (%) | ||
| 0 | 14 (20) | 20 (30) |
| 1 | 18 (26) | 13 (19) |
| 2 | 30 (43) | 27 (40) |
| 3 | 6 (9) | 7 (10) |
| 4 | 1 (1) | 0 (0) |
| Previous contraceptive method—N (%) | ||
| Pill | 4 (6) | 3 (4) |
| Cu-IUD | 5 (7) | 9 (13) |
| Barrier—mainly condom* | 53 (77) | 52 (78) |
| Rhythm/withdrawal/ spermicide | 3 (4) | 2 (3) |
| None | 4 (6) | 1 (1) |
| Heaviness of menstrual periods in last 6 months—N (%) | ||
| Light loss | 2 (3) | 0 (0) |
| Moderate loss | 25 (38) | 25 (40) |
| Heavy loss | 26 (40) | 29 (46) |
| Very heavy loss | 12 (18) | 9 (14) |
| Bleeding or spotting in quarter or more of menstrual cycles in past year—N/n (%) | 10/66 (15) | 10/62 (16) |
| Ever stopped using method of contraception due to following reason | ||
| Unacceptable weight gain— N/n (%) | 20/54 (37) | 15/58 (26) |
| Irregular bleeding or spotting—N/n (%) | 16/53 (30) | 12/57 (21) |
| Unacceptably heavy bleeding—N/n (%) | 10/51 (20) | 6/57 (11) |
| Periods stopped altogether— N/n (%) | 1/48 (2) | 1/57 (2) |
*Includes the one woman (in Placebo group) who was using diaphragm.