Table 3:
Subject disposition in the Phase 3 trials (n=2,308) analysis set of women using the SA/EE contraceptive vaginal system, and Reasons for discontinuation.
| Disposition | All Dose SA/EE CVS (N=2,843) | Phase 3 SA/EE 150/13 CVS (N=2,308) | Phase 3 SA/EE 150/13 CVS BMI Subgroups | |
|---|---|---|---|---|
| <29.0 kg/m2 (N=2,099) | >29.0 kg/m2 (N=209) | |||
| Completed the Study | 1761 (62) | 1332 (58)* | 1296 (62) | 36 (17) |
|
Discontinued Prematurely |
1082 (38) | 976 (42) | 803 (38) | 173 (83) |
| Adverse Event** | 328 (12) | 281 (12) | 267 (13) | 14 (7) |
| Withdrew Consent | 228 (8) | 214 (9) | 191 (9) | 23 (11) |
| Lost to Follow-up | 220 (8) | 197 (9) | 184 (9) | 13 (6) |
| Eligibility*** | 147 (5) | 147 (6) | 31 (1) | 116 (56) |
| Pregnancy | 63 (2) | 54 (2) | 50 (2) | 4 (2) |
| Compliance | 62 (2) | 49 (2) | 47 (2) | 2 (<1) |
| Expulsions | 33 (1) | 33 (1) | 32 (2) | 1 (<1) |
| Other | 3 (<1) | 1 (<1) | 1 (<1) | 0 |
All data are presented as n (%).
SA = segesterone acetate; EE = ethinyl estradiol; CVS = Contraceptive vaginal system; BMI= Body Mass Index.
1332 completed the study and 999 completed the 13 cycles of CVS use. Not all completers who were enrolled late in the study completed 1 year due to the expiration of the drug
Most Common AE leading to discontinuation: headache 30(1.3%); nausea 28(1.2%); Vaginal discharge/vulvovaginal mycotic infection 30(1.3%); abdominal pain 30 (1.3%). Metrorrhagia/menorrhagia occurred in 7% of the subjects and 1.7% discontinued for this reason (n=39)
The Sponsor discontinued subjects with a BMI >29.0 kg/m2 during the study.