Clinical Trial Search

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

Primary: Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians — 1.76; 0.55; 1.38; 0.97 Score on a Scale

Primary: Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) — 46.7; 65.5; 53.4; 61.8 percentage of parabasal cells

Primary: Female Sexual Function Index (FSFI) Score Compared to Baseline — 4.14; 5.95 score on a scale

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

Primary: Change in Symptom Scores of Vaginal Dryness — -2 units on a scale — p=<0.001

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: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) — -3.7; -31.7 percentage of parabasal cells

Primary: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit — 2.49; 2.46; 2.50; 2.50 score on a scale

Primary: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear — 60.66; 56.74; 59.54; 62.22 percentage of parabasal cells

Primary: Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics — 63.6; 55.8; 66.0 units on a scale — p=0.1675

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: Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range — 0; 4 participants

Primary: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear — 68.48; 65.72; 65.05; 66.86 Percentage of parabasal cells

Primary: Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug — -1.5; -3 score on a scale — p=0.08

Primary: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear — 1.04; 1.02; 2.78; 11.22 Percentage of superficial cells

Primary: The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared…

Primary: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment — 2.5; 2.5; -1.2; -1.4 score on a scale

Primary: Change of Pain Score of Female Sexual Function Index — 1.15; 1.05 units on a scale

Primary: Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium — 421; 36 Participants

Primary: Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment…

Primary: Mean Change in the Symptom Identified by the Patient to be Most Bothersome — -1.71; -1.77; -1.11; -1.10 Scores on a scale

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

Primary: Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) — 1.8; 1.8; 1.7 scores on a scale

Primary: Percentage of Subjects Identified as Responders — 36.8; 32.0; 0.8 percentage of responders

Primary: Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells) — -54.4; -4.8 Percentage of Parabasal Cells — p=<0.0001

Primary: Number of Subjects With Treatment Emergent Adverse Events — 3; 2; 4; 3 Participants

Primary: Number of Participants With Observed Local Erythema — 0 participants

Primary: Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies — 0; 0; 0; 0 percentage of participants

Primary: Total Female Sexual Function Index (FSFI) Score — 8.691; 18.783 units on a scale — p=<0.0005