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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=29 Monoclonal Antibody-based Multipurpose Microbicides
HIV · Sexually Transmitted Infections (STI)
Primary: Frequency of Use — 1.14; 1.31; 0.00; 0.00 units on a scale
N/A N=48 A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users
Microbicide Delivery System Acceptability
Primary: User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means — 3.64; 3.86; 4.35; 3.83 units on a scale
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
Phase 4 N=43 Topical Antimicrobial Effectiveness Testing
Antimicrobial Effectiveness
Primary: Antimicrobial Efficacy — 2.21; 2.25 log 10 colony forming units / cm^2 — p=< 0.05
N/A N=18 Developing Rectal USPE Measures
Microbicide Delivery System Perceptibility and Acceptability
Primary: User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means — 3.67; 3.29; 3.86; 3.42 units on a scale
N/A N=217 Rectal Microbicide Acceptability, Tolerability and Adherence
HIV Prevention
Primary: Acceptability of Future Product Use — 143; 132; 143; 56 Participants
Phase 2 N=12 Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
HIV Infections · HSV-2 Genital Herpes
Primary: HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup) — 96 percent anti-viral activity
N/A N=482 Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
Vaginal Microflora
Primary: Percentage of Subjects Showing Unfavorable Changes in Primary Microflora — 52.7; 52.9; 60.0 Percentage of Participants
Phase 2 N=40 Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
Trichomonas Vaginitis
Primary: Percentage of Participants Cured of Vaginal Trichmonas — 90; 90; 88 percentage of participants
Phase 3 N=250 A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Bacterial Vaginosis
Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 59; 19 Participants — p=<0.001
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
Phase 3 N=251 A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Bacterial Vaginosis
Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 68; 25 Participants — p=<0.001
N/A N=1,210 HPV Typing Between Self- and Physician-sampled
Human Papillomavirus Infection · Self Sampling · Vaginal Discharge
Primary: Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. — 581; 611; 589; 559 Participants
Phase 1 N=13 Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults
HIV Infections
Primary: Frequency of Grade 2 or Higher Adverse Events (AEs) — 1; 2; 0 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=234 Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Bacterial Vaginosis · Candidiasis · Trichomoniasis
Primary: Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights…
Phase 2 N=128 A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
HIV-1 Infections
Primary: The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings. — 23; 28; 28 Participants
Phase 2 N=168 Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
HIV Infections
Primary: Self-reported Adherence to Each Regimen — 94; 93.8; 93.9 percentage of expected doses
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
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
Phase 2 N=198 Feasibility of Delphi Screener for Cervical Cytology
Cervical Neoplasia
Primary: Sensitivity and Specificity — 0.86; 0.80 % of participants correctly diagnosed
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
Phase 4 N=35 Topical Antimicrobial Effectiveness Testing
Antimicrobial Effectiveness
Primary: Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the…
N/A N=32 Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
Microbicide Delivery System Perceptibility and Acceptability
Primary: User Perception Scale Scores — 3.31; 3.36; 2.12; 2.62 units on a scale
N/A N=94 In-use Study of Four Different Tampons
Menstruation
Primary: Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health — 0; 0; 0; 0 Participants
N/A N=59 Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Pain
Primary: Change in Pain From Baseline to IUD Insertion — 61; 68 change in visual analog scale score
N/A N=756 Pap Smear Collection With the Papette Brush
Cervical Cancer Screening
Primary: Specimen Adequacy — 335; 371 Participants — p=.75
N/A N=56 Mobile HIV Prevention App for Black Women
Mobile Phone Use · Hiv · Stigma, Social
Primary: Retention Rate — 20; 24 Participants
N/A N=104 rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Sexually Transmitted Infection
Primary: Change in Frequency of Recent Dual Method Use — 3.17; 3.45 score on a scale — p=.177