Clinical Trial Search

Primary: Change in VSQ Score — -3.3; -3.7 score on a scale

Primary: Change in the Relative Abundance of Lactobacillus — 0.143 proportion of total microbes

Primary: Most Bothersome Symptom (MBS) Severity — -1.2; -1.0; -0.2; -1.4 units on a scale — p=0.25

Primary: Vaginal Dryness — -5.48; -5.76 units on a scale

Primary: Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment — 2.66 score on a scale

Primary: The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary — 81 percent reduction

Primary: Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12 — 94; 96; 87 Participants

Primary: Change From Baseline to Week 12 in the Severity of Vaginal Dryness — 15; 13; 13; 9 Participants — p==0.304

Primary: Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 — -1.92; -2.75; -2.75; -1.39 VMS per day

Primary: Change in Vaginal Microbiota — 2.75 change in percent relative abundance

Primary: Occurrence of UTI During Randomization — 8; 10 Participants

Primary: Percentage of Participants With Insertion Success — 32 Participants

Primary: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 — -23.7; -1.9 percentage of cells — p=<0.0001

Primary: 6 Weeks - Total FSFI Score — 26.0; 17.4 score on a scale — p=0.109

Primary: Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) — 8.4; 9.0; 9.9; 8.9…

Primary: Pelvic Floor Muscle Function Measured by Digital Palpation — 4.00; 3.25; 3.75 score on a scale

Primary: Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy — 0; 1; 8; 4 Participants

Primary: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) and Number of Participants With Mild, Moderate and Severe AE — 54; 52; 45; 51 Participants

Primary: Tolerability of Gabapentin — 22; 4 Participants

Primary: Number of Participants Recruited — 12; 0 Participants

Primary: Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months — 82; 90 Percentage of subjects

Primary: Change From Baseline to Week 8 in the Number of Voids/24 Hours — -1.06; -1.44; -1.78; -2.41 voids/24 hrs.

Primary: Average Number of Voids Per Day — NA; NA Average Number of Voids

Primary: Co-Primary Efficacy Endpoint - Vaginal Superficial Cells — 17.50; 16.72; 23.20; 5.63 percentage of vaginal superficial cells — p=< 0.0001

Primary: Response to Therapy — 15; 29 Participants

Primary: Vulvovaginal Symptoms Questionnaire — 8; 7.88; 5.93; 5.93 score on a scale

Primary: Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG — -18; 10; 11; -15 microvolts — p=>0.05

Primary: Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment — -7.0; -6.9; -5.4 Hot flashes — p=0.0024

Primary: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes — -19.54; -20.55; -15.99 Awakenings

Primary: Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology — -0.5; 1.8; -0.3; -0.2 Celsius degree