Skip to main content
. 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 5.

Change from Baseline of Vital Signs Data- SA/EE 150/13 CVS Analysis Set (N = 2,308).

Vital Signs Baseline Mean (SD) Median Change (Min/Max)
Diastolic BP (mmHg) 68.7 (7.7) 0.5 (−28/30a)
Systolic BP (mmHg 108.4 (10.1) 1.0 (−37/40a)
Pulse (bpm) 73.9 (10.3) 2.0 (−42/47)
Weight (kg) 64.3 (10.6) 0.2 (−17b/17.7c)
Body Mass Index (kg/m2) 24.1 (3.7) 0.09 (−6.6/6.6)

SA = segesterone acetate; EE = ethinyl estradiol; CVS = contraceptive vaginal system

BP = blood pressure; Min= minimum; Max=maximum

a.

Eight subjects reported hypertension as an AE and four of them received short term antihypertensive treatment. Only one of these discontinued for hypertension of 132/102

b.

Three (3) subjects reported weight decrease as an AE

c.

Thirty-five (35) subjects reported weight increase as an AE, 9 of these discontinued for the weight increase of 4–10 kg and 1 of these was discontinued for BMI >29.0