Clinical Trial Search

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

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

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

Primary: Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness — -1.22; -1.26; -0.84 Units on a scale

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: 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: Vulvar Assessment Scale (VUAS) — 0.10; 0.20 score on a scale

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

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

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: 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: Number of Participants With Endometrial Biopsy Results at Final Visit — 3; 10; 7; 166 Participants

Primary: Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators — 1.85; 0.65; 0.65; 0.73 score on…

Primary: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse — 18; 8 Participants

Primary: The Primary Efficacy Endpoint — 49; 59; 52; 63 participants — p=<0.0001

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: Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography — 8 points improvement on VGTA scale — p=0.05

Primary: Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment — 26.9; 3.2 vaginal health index — p=<0.001

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

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

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 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: Serum Concentrations of Estriol (E3) — 0; 0.91; 3.83; 1.58 pg/ml

Primary: Global Response Assessment — 5 participants

Primary: Vaginal Wall Composition: Epithelium (Intention to Treat) — 413.9; 314.1 microns — p=0.21