Table 2.

Phase III efficacy of ospemifene: vaginal pH and symptoms of vulvar and vaginal atrophy

Study	Vaginal pH (Δ)a			Most bothersome symptom (Δ)a			Number of patients (n)
	Placebo	30 mg	60 mg	Placebo	30 mg	60 mg	Placebo	30 mg	60 mg
First pivotal phase III33	−0.10	−0.67b	−1.01b	−0.84c/−0.89d	−1.22b,c/−1.02d	−1.26b,c/−1.19d,e	268	282	276
Phase III dyspareunia (ITT)34	−0.07	–	−0.94f	−1.2	–	−1.5f	302	–	303
Phase III dyspareunia (PP)34	−0.08	–	−1.1f	−1.2	–	−1.6g	251	–	255
Phase III vaginal dryness (ITT)35	−0.25	–	−0.95b	−1.1	–	−1.3	154	–	160
Phase III vaginal dryness (PP)35	−0.23	–	−0.99b	−1.1	–	−1.4h	137	–	127

Notes:

^aFrom baseline to 12 weeks.

^bP<0.001 compared to placebo.

^cVaginal dryness.

^dDyspareunia.

^eP=0.023 compared to placebo.

^fP<0.0001 compared to placebo.

^gP=0.0004 compared to placebo.

^hP=0.014 compared to placebo.

Abbreviations: ITT, intent to treat; PP, per protocol.