30 closest matches · ranked by relevance
Vulvovaginal Atrophy · Menopause · Dyspareunia
Primary: Co-Primary Efficacy Endpoint - Vaginal Superficial Cells — 17.50; 16.72; 23.20; 5.63 percentage of vaginal superficial cells — p=< 0.0001
Postmenopausal Vulvovaginal Atrophy
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
Vaginal Atrophy
Primary: Change From Baseline to Week 12 in the Severity of Vaginal Dryness — 15; 13; 13; 9 Participants — p==0.304
Atrophy · Vaginal Diseases
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
Vaginal Atrophy
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
Vaginal Atrophy
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
Vulvar Atrophy
Primary: Number of Subjects With Treatment Emergent Adverse Events — 3; 2; 4; 3 Participants
Vaginal Atrophy
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
Vaginal Dryness
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
Atrophy
Primary: Percentage of Subjects Identified as Responders — 36.8; 32.0; 0.8 percentage of responders
Menopause · Vulvovaginal Atrophy · Painful Intercourse
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
Menopause
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
Vaginal Atrophy
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
Menopause · Postmenopausal Vaginal Atrophy
Primary: Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies — 0; 0; 0; 0 percentage of participants
Vaginal Atrophy
Primary: Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium — 421; 36 Participants
Vulvovaginal Atrophy
Primary: Number of Participants With Endometrial Biopsy Results at Final Visit — 3; 10; 7; 166 Participants
Vulvovaginal Atrophy
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…
Vulvovaginal Atrophy
Primary: Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment…
Dyspareunia
Primary: Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug — -1.5; -3 score on a scale — p=0.08
Vaginal Atrophy
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
Atrophy · Vaginal Diseases
Primary: Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear — -3.0; -2.8; -24.1; -26.8 percentage of parabasal cells
Vaginal Atrophy
Primary: Vulvar Assessment Scale (VUAS) — 0.10; 0.20 score on a scale
Atrophy of Vagina · Menopause · Dyspareunia (Female)
Primary: Most Bothersome Symptom (MBS) Severity — -1.2; -1.0; -0.2; -1.4 units on a scale — p=0.25
Vulvovaginal Atrophy
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
Atrophy · Vaginal Diseases
Primary: Incidence of Adverse Events (AEs) — 220; 67; 34; 13 Participants
Atrophy · Vaginal Diseases
Primary: Incidence of Adverse Events (AEs) — 38; 44; 22; 11 Participants
Pelvic Organ Prolapse · Urogenital Prolapse · Vaginal Vault Prolapse
Primary: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse — 18; 8 Participants
Atrophy · Vaginal Diseases
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
HIV Infection · Vaginal Atrophy · Menopause
Primary: Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy — 0; 1; 8; 4 Participants
Menopause Hot Flashes
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