Table 4.
Summary of Adverse Reactions Occurring in >2% of Subjects - Phase 3 trials SA/EE contraceptive vaginal system Analysis Set (N=2,308)
| Adverse Reaction | Subjects (%) with Adverse Reactions |
|---|---|
| Any event | 1,602 (69) |
| Headache | 601 (26) |
| Nausea | 420 (18) |
| Vaginal discharge | 242 (10) |
| Uterine spasm | 225 (10) |
| Vulvovaginal mycotic infection | 173 (7) |
| Metrorrhagiaa | 160 (7) |
| Breast tenderness | 134 (6) |
| Vomiting | 108 (5) |
| Genital pruritus female | 92 (4) |
| Urinary tract infection | 92 (4) |
| Migraine | 77 (3) |
| Vaginal candidiasis | 70 (3) |
| Libido decreased | 69 (3) |
| Acne | 66 (3) |
| Mood swings | 60 (3) |
| Dizziness | 58 (3) |
| Dyspareunia | 56 (2) |
| Vulvovaginal discomfort | 56 (2) |
| Withdrawal bleedb | 56 (2) |
| Breast pain | 49 (2) |
All data are presented as n (%).
Discontinuation rates for the common adverse reactions were: Headache including migraine n= 30 (1.3%); Vaginal discharge/vulvovaginal mycotic infections n=30 (1.3%); Nausea/vomiting n=28 (1.2%) and metrorrhagia/menorrhagia n=39 (1.7%)
SA = segesterone acetate; EE = ethinyl estradiol; CVS = Contraceptive vaginal system
Metrorrhagia includes verbatim terms of: irregular bleeding, irregular spotting, breakthrough bleeding, breakthrough spotting, spotting, frequent spotting, prolonged spotting.
Withdrawal bleed includes verbatim terms of: heavy bleeding with menses, bleeding very much, prolonged bleeding with menses, frequent bleeding with menses.