Table 2.

Menstrual Cycle Symptom Scores for Primary and Secondary Outcome Measures, by Random Assignment

	Number of Participants		PMTS		IDS-C		CGI-S		CGI-I
Visit	Act.	Pla.	Active	Placebo	Active	Placebo	Active	Placebo	Active	Placebo
Baseline	125	127	22.3 (4.8)	21.4 (4.5)	35.4 (10.7)	32.8 (10.4)	4.5 (0.7)	4.5 (0.6)	–	–
Cycle 1	110	123	15.6 (7.3)	16.8 (6.0)	23.7 (12.3)	24.0 (11.4)	3.4 (1.0)	3.8 (0.9)	2.7 (1.1)	3.2 (1.0)
Cycle 2	104	112	14.1 (6.9)	15.6 (6.1)	21.0 (11.7)	22.8 (10.6)	3.1 (1.2)	3.3 (1.1)	2.4 (1.0)	2.7 (1.1)
Cycle 3	100	101	13.0 (8.0)	14.0 (5.8)	19.2 (13.1)	19.6 (10.0)	2.8 (1.3)	3.0 (1.0)	2.3 (1.3)	2.4 (1.0)
Cycle 4	95	98	12.9 (6.7)	13.9 (6.3)	17.3 (11.1)	19.1 (9.9)	2.6 (1.2)	2.9 (1.2)	2.1 (1.2)	2.5 (1.3)
Cycle 5	88	85	11.4 (6.3)	12.4 (6.3)	15.2 (9.9)	16.7 (10.4)	2.4 (1.0)	2.7 (1.1)	2.0 (1.0)	2.1 (1.2)
Cycle 6	88	88	11.7 (6.8)	12.8 (6.9)	15.5 (10.7)	17.8 (11.0)	2.2 (1.1)	2.5 (1.3)	1.8 (0.9)	2.2 (1.3)
Average Change from Baseline	88	88	−10.6 (6.6)	−8.9 (7.4)	−20.0 (11.4)	−15.3 (12.5)	−2.3 (1.2)	−1.9 (1.4)	−0.9 (1.2)**	−0.8 (1.4)**
Group			F(1,249)=1.6, p=0.21		F(1,245)=0.4, p=0.54		χ2(1)=6.2, p=0.01		χ2(1)=6.7, p=0.01
Time			F(6,447)=131.8, p<.001		F(6,1210)=60.7, p<.001		χ2(6)=182.8, p<.001		χ2(5)=29.9, p<.001
Group by Time			F(6,448)=2.1, p=0.06		F(6,1183)=2.6, p=0.02		χ2(6)=7.5, p=0.28
Estimated Mean difference from baseline to end point between active vs. placebo (95% CI)			1.88 (0.01 – 3.75)		5.14 (1.97 – 8.31)		0.59 (0.30 – 1.19)		0.55 (0.30 – 1.02)*

^*Represents difference between groups at end-point only

^**Represents average change from Cycle 1 to end-point