Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital^® Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study

Figures & data

Table 1 Subject Demographic and Baseline Characteristics (Mean, Standard Deviation or Number of Observation and Percent)

Patient Characteristics	Oxytocin Gel (n=79)	Aqueous Hypromellose-Based Vaginal Gel (n=78)
Age in years (mean, std)	58.0 (3.9)	58.7 (3.1)
Height in cm (mean, std)	166 (6)	166 (6)
Weight in kg (mean, std)	69.93 (10.20)	69.42 (9.60)
Body Mass Index (mean, std)	25.3 (3.5)	25.3 (3.1)
Use of tobacco
Never (n, %)	45 (57%)	44 (56%)
Current (n, %)	3 (4%)	4 (5%)
Former (n, %)	30 (38%)	30 (38%)
Missing information (n, %)	1 (1%)	0 (0%)
Alcohol consumption
Never (n, %)	7 (9%)	7 (9%)
Current (n, %)	72 (91%)	71 (91%)

Figure 1 Subject disposition.

Table 2 MBS: Comparison of Oxytocin Gel versus Aqueous Hypromellose-Based Vaginal Gel Using the Change from Baseline Within (Wilcoxon Signed Rank Test) and Between (Wilcoxon Rank Sum Test) the Groups

Group	Time	Mean	P-value
Oxytocin gel (n=79)	Baseline	2.61	NA
	Week 4	1.78	NA
	Week 12	1.44	NA
	Week 4 - baseline	−0.82	0.0000
	Week 12 - baseline	−1.16	0.0000
Aqueous Hypromellose-based vaginal gel (n=78)	Baseline	2.45	NA
	Week 4	1.55	NA
	Week 12	1.17	NA
	Week 4 - baseline	−0.90	0.0000
	Week 12 - baseline	−1.28	0.0000
Oxytocin gel compared to Aqueous Hypromellose-based vaginal gel. The mean values are calculated by subtracting the mean values for each treatment group (Oxytocin gel minus Aqueous Hypromellose-based vaginal gel)	Baseline	0.16	0.0556
	Week 4	0.23	0.1445
	Week 12	0.28	0.1182
	Week 4 - baseline	0.07	0.5582
	Week 12 - baseline	0.12	0.3698

Table 3 pH: Comparison of Oxytocin Gel versus Aqueous Hypromellose-Based Vaginal Gel Using the Change from Baseline Within (Wilcoxon Signed Rank Test) and Between (Wilcoxon Rank Sum Test) the Groups

Group	Time	Mean	P-value
Oxytocin gel (n=79)	Baseline	7.01	NA
	Week 4	6.64	NA
	Week 12	6.56	NA
	Week 4 - baseline	−0.38	0.0011
	Week 12 - baseline	−0.46	0.0002
Aqueous Hypromellose-based vaginal gel (n=78)	Baseline	7.00	NA
	Week 4	6.47	NA
	Week 12	6.27	NA
	Week 4 - baseline	−0.53	0.0000
	Week 12 - baseline	−0.73	0.0000
Oxytocin gel compared to Aqueous Hypromellose-based vaginal gel. The mean values are calculated by subtracting the mean values for each treatment group (Oxytocin gel minus Aqueous Hypromellose-based vaginal gel)	Baseline	0.01	0.6965
	Week 4	0.17	0.3293
	Week 12	0.29	0.1524
	Week 4 - baseline	0.16	0.4548
	Week 12 - baseline	0.28	0.1350

Table 4 Vaginal Cytology (Superficial Cells): Comparison of Oxytocin Gel versus Aqueous Hypromellose-Based Vaginal Gel Using the Change from Baseline Within (Wilcoxon Signed Rank Test) and Between (Wilcoxon Rank Sum Test) the Groups

Group	Time	Mean	P-value
Oxytocin gel (n=79)	Baseline	0.25	NA
	Week 4	3.15	NA
	Week 12	4.03	NA
	Week 4 - baseline	2.86	0.0001
	Week 12 - baseline	3.77	0.0000
Aqueous Hypromellose-based vaginal gel (n=78)	Baseline	0.45	NA
	Week 4	2.82	NA
	Week 12	2.38	NA
	Week 4 - baseline	2.33	0.0006
	Week 12 - baseline	1.94	0.0003
Oxytocin gel compared to Aqueous Hypromellose-based vaginal gel. The mean values are calculated by subtracting the mean values for each treatment group (Oxytocin gel minus Aqueous Hypromellose-based vaginal gel)	Baseline	−0.20	0.2668
	Week 4	0.34	0.9505
	Week 12	1.64	0.5851
	Week 4 - baseline	0.53	0.8829
	Week 12 - baseline	1.84	0.4715

Table 5 Vaginal Dryness: Comparison of Oxytocin Gel versus Aqueous Hypromellose-Based Vaginal Gel Using the Change from Baseline Within (Wilcoxon Signed Rank Test) and Between (Wilcoxon Rank Sum Test) the Groups

Group	Time	Mean	P-value
Oxytocin gel (n=79)	Baseline	2.46	NA
	Week 4	1.51	NA
	Week 12	1.30	NA
	Week 4 - baseline	−0.95	0.0000
	Week 12 - baseline	−1.15	0.0000
Aqueous Hypromellose-based vaginal gel (n=78)	Baseline	2.18	NA
	Week 4	1.27	NA
	Week 12	0.97	NA
	Week 4 - baseline	−0.91	0.0000
	Week 12 - baseline	−1.21	0.0000
Oxytocin gel compared to Aqueous Hypromellose-based vaginal gel. The mean values are calculated by subtracting the mean values for each treatment group (Oxytocin gel minus Aqueous Hypromellose-based vaginal gel)	Baseline	0.28	0.0026
	Week 4	0.24	0.0633
	Week 12	0.33	0.0529
	Week 4 - baseline	−0.04	0.7691
	Week 12 - baseline	0.05	0.8138

Table 6 Dyspareunia: Comparison of Oxytocin Gel versus Aqueous Hypromellose-Based Vaginal Gel Using the Change from Baseline Within (Wilcoxon Signed Rank Test) and Between (Wilcoxon Rank Sum Test) the Groups

Group	Time	Mean	P-value
Oxytocin gel (n=79)	Baseline	2.54	NA
	Week 4	1.95	NA
	Week 12	1.62	NA
	Week 4 - baseline	−0.60	0.0000
	Week 12 - baseline	−0.88	0.0000
Aqueous Hypromellose-based vaginal gel (n=78)	Baseline	2.41	NA
	Week 4	1.86	NA
	Week 12	1.41	NA
	Week 4 - baseline	−0.55	0.0000
	Week 12 - baseline	−1.05	0.0000
Oxytocin gel compared to Aqueous Hypromellose-based vaginal gel. The mean values are calculated by subtracting the mean values for each treatment group (Oxytocin gel minus Aqueous Hypromellose-based vaginal gel)	Baseline	0.13	0.2052
	Week 4	0.09	0.5027
	Week 12	0.21	0.2421
	Week 4 - baseline	−0.05	0.7278
	Week 12 - baseline	0.17	0.4365

Table 7 Two-Sided p-values for the Other Individual VVA Symptoms (All Changes are Improvements)

Group	Symptom	Week 4 - Baseline	Week 12 -Baseline
Oxytocin gel (n=79)	Itching	0.0000	0.0004
	Dysuria	0.0006	0.0004
	Bleeding	0.0225	0.0129
Aqueous Hypromellose-based vaginal gel (n=78)	Itching	0.0000	0.0000
	Dysuria	0.0000	0.0001
	Bleeding	0.0024	0.0013