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. Author manuscript; available in PMC: 2020 Jul 13.
Published in final edited form as: Contraception. 2019 Mar 1;99(6):323–328. doi: 10.1016/j.contraception.2019.02.001

Table 1.

Summary of SA/EE contraceptive vaginal system (CVS) Safety Analysis Studies

Population / Analysis Set Product Studied Doses Studied (mcg/day) Total Subjects
All-Dose SA/EE CVS Phase 3a and Pilot SA/EE CVS 50/20
150/13
150/20
200/13		 2,843
All SA/EE 150/13b CVS Phase 3a and Pilot SA/EE CVS 150/13 2,569
Phase 3 Trials SA/EE 150/13b CVS Phase 3 SA/EE CVSa 150/13 2,308

SA = segesterone acetate

EE = ethinyl estradiol

CVS = Contraceptive vaginal system

a

Formulation intended for marketing

b

The in-vitro release data initially supported an average daily release of 150/15 micrograms per day for SA and EE, respectively. Estimates from an ex-vivo study results indicate 150/13 micrograms per day for SA and EE, respectively.

The ALL DOSE SA/EE CVS DATASET(N=2843) and the SA/EE 150/13 CVS DATASET (N=2,569) are used as the denominator for program-wide serious adverse event (SAE) assessments; and the PHASE-3 TRIALS SA/EE CVS DATASET (N=2,308) are used as the denominator for the pivotal trials adverse events and labs assessments.