N/A N=64 A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101
Safety of Vaginal Film Use
Primary: Grade 2 or Higher Urogenital System Adverse Event Related to Film Use — 2 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=37 Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048
Pharmacokinetics · Safety
Primary: Number of Participants With Grade 2 or Higher Adverse Events — 2; 5 Participants — p=.025
N/A N=30 Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations
Safety · Acceptability
Primary: Number of Participants That Successfully Insert Vaginal Film — 8; 8; 22; 22 Participants — p=>.99
Early Phase 1 N=20 An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film
Contraception
Primary: Surrogate Contraceptive Efficacy — 25.86; 0.04; 47.39 sperm per high power field — p=<0.0001
N/A N=30 A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects
Erythema · Edema
Primary: Number of Participants With Observed Local Erythema — 0 participants
Phase 1 N=30 Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring
HIV
Primary: Grade 1 Genitourinary Events or Higher as Defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events — 7; 1 Adverse events
Phase 3 N=164 Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
Contraception: Optional Applicator for Insertion of Vaginal Ring
Primary: Percentage of Participants With Successful Ring Insertion — 100; 100 Percentage of participants
N/A N=34 A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
Erythema · Edema
Primary: Number of Subjects With Observed Local Erythema Based on 5 Point Scale — 0 Participants
N/A N=32 A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects
Erythema · Edema
Primary: Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale — 0 Participants
N/A N=30 A Single-Center, Clinical Study to Evaluate the Safety of a Fragranced Personal Lubricant in Healthy Female Subjects
Erythema · Edema
Primary: Number of Participants With Observed Local Erythema — 0 participants
N/A N=25 Comparative Safety Study of Two Vaginal Applicators With Tenofovir
Microbicide Applicator
Primary: Number of Colposcopic Findings (Baseline and After One Week of Product Use) — 3; 0; 2; 0 colposcopic findings — p=0.4870
N/A N=72 Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness
Menopause Related Conditions · Postmenopausal Symptoms
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
Phase 2 N=96 Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
Human Immunodeficiency Virus
Primary: Safety of Dapivirine (25 mg) Administered in a Silicone Elastomer Vaginal Matrix Ring in HIV-uninfected Postmenopausal Women, When Inserted Once Every 4 Weeks During 12…
N/A N=82 A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
Coitus
Primary: Number of Participants Showing Change From Baseline in Irritation Scores — 0; 0 Participants
Phase 3 N=336 Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Menopause · Postmenopausal Vaginal Atrophy
Primary: Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies — 0; 0; 0; 0 percentage of participants
Phase 4 N=81 Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Bacterial Vaginosis
Primary: Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests — 5.59; 5.22; 4.91; 7.41 log10 copies/ml — p=0.011
Phase 2 N=247 Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
HIV Infections
Primary: Number of Participants With Grade 2 or Higher Adverse Events (AEs) — 36; 36; 88; 87 Participants — p=0.92
Phase 2 N=105 Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Vulvodynia
Primary: Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) — 1.8; 1.8; 1.7 scores on a scale
N/A N=44 Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action
Dyspareunia · Vaginal Dryness
Primary: Female Sexual Function Index (FSFI) Score Compared to Baseline — 4.14; 5.95 score on a scale
Phase 3 N=301 Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
Atrophy · Vaginal Diseases
Primary: Incidence of Adverse Events (AEs) — 220; 67; 34; 13 Participants
Phase 3 N=450 Contraceptive Effectiveness and Safety of the SILCS Diaphragm
Contraception
Primary: Percent Probability of Pregnancy Among Users of the SILCS Diaphragm Used With Contraceptive Gel Over 6 Months of Typical Use — 12.5; 9.6 percent probability
N/A N=70 Safety Study for an All-in-One Body and Personal Lubricant
Lubricating Agents
Primary: Number of Subjects With Irritation Score of "0" at Baseline and One Week — 35; 35; 35; 35 Participants
N/A N=14 Hormonal Contraception and Vaginal Health
Contraceptive Usage · Vaginal Epithelial Disruption
Primary: Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. — 0.01; -0.005; -0.02; .007 mm
N/A N=38 Safety and Acceptability Study of a Non-Hormonal Ring
Contraception
Primary: Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use. — 0; 26 Participants
Phase 3 N=302 The Vaginal Health Trial
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
N/A N=1,959 Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
HIV Infections
Primary: HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. — 82; 61 Participants
Phase 2 N=17 Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
Vulvar Atrophy
Primary: Number of Subjects With Treatment Emergent Adverse Events — 3; 2; 4; 3 Participants
N/A N=511 A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom
Contraception
Primary: 6 Month Pregnancy Probabilities With Typical Use — 0.5; 1.4; 4.0 percentage of probability
Phase 1 N=12 Safety Study of Lactobacillus Administered Vaginally to Healthy Women
Bacterial Vaginosis
Primary: Safety of LACTIN-V in Healthy Pre-menopausal Women. — 0; 0; 0; 0 participants
Phase 3 N=764 Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
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