Table 1.

Phase III efficacy of ospemifene: vaginal maturation index

Study	Parabasal cells (% Δ)a			Superficial cells (% 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	4.0	−21.9b	−30.1b	2.2	7.8b	10.8b	268	282	276
Phase III dyspareunia (ITT)34	0.0	–	−40.2c	1.7	–	12.3c	302	–	303
Phase III dyspareunia (PP)34	−0.2	–	−42.1c	1.9	–	13.2c	251	–	255
Phase III vaginal dryness (ITT)35	−3.9	–	−31.7b	0.0	–	7.0b	154	–	160
Phase III vaginal dryness (PP)35	−4.7	–	−36.6b	0.0	–	8.0b	137	–	127
Phase III long-term safety38	0	–	−40c	0	–	5c	63	–	363

Notes:

^aBaseline to week 12.

^bP<0.001 compared to placebo.

^cP<0.0001 compared to placebo.

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