Clinical trials: Irritation; Vagina
Bacterial Vaginosis
DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
This is a multicenter, randomized, double-blind, placebo-controlled study of DARE-BV1 (clindamycin phosphate vaginal gel, 2%) (QD x 1 day) compared to placebo vaginal gel (HEC Universal Placebo Gel) (QD × 1 day) for the treatment…
- Trial name
- NCT04370548
- Testing
- DARE-BV1clindamycin phosphate vaginal gel, 2%
- Where
- 10 sites in United States
- Volunteers
- 307 people
- Sponsor
- Daré Bioscience, Inc.
Recurrent Bacterial Vaginosis
Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.
- Trial name
- NCT05033743
- Testing
- Secnidazole 2 GM Oral Granules
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Indiana University
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Vulvovaginal Candidiasis
The Study Of Fluconazole For Vulvovaginal Candidiasis
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas.
- Trial name
- NCT01806623
- Testing
- Fluconazole
- Where
- 10 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Pfizer
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- Vanish 306 (NCT03987620)
- Testing
- Ibrexafungerp
- Where
- 41 sites in United States, Bulgaria
- Volunteers
- 455 people
- Sponsor
- Scynexis, Inc.
Vaginitis Gardnerella
Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
This is a randomized, double-blind, placebo-controlled Phase 2 study designed to determine if amoxicillin will eradicate vaginal colonization/infection with Gardnerella vaginalis (GV) when administered to women who are…
- Trial name
- NCT03211156
- Testing
- Amoxicillin
- Where
- 2 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Female Urogenital Diseases, Vaginal Atrophy
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of…
- Conditions
- Female Urogenital Diseases, Vaginal Atrophy, Postmenopausal Atrophic Vaginitis, Genitourinary Disease
- Trial name
- IMPLORE (NCT03996603)
- Testing
- Conjugated Estrogens Cream
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Vaginitis Bacterial, Cervicitis
Empiric Therapy of Mucopurulent Cervicitis (MPC)
Mucopurulent cervicitis (MPC) is a syndrome with associated symptoms including mucopurulent discharge (mucus and pus) from the cervix and other signs of inflammation such as easily induced cervical bleeding.
- Trial name
- NCT01072136
- Testing
- Azithromycin, Cefixime
- Where
- 4 sites in United States
- Volunteers
- 87 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bacterial Vaginosis
Rwanda Vaginal Microbiota Restoration Study
A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.
- Trial name
- VMB (NCT02459665)
- Testing
- Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence, Prophylactic use of metronidazole pills (500 mg), Vaginal Lcr35-containing probiotic for prevention of BV recurrence
- Volunteers
- 68 people
- Sponsor
- Janneke van de Wijgert
Vaginosis, Bacterial
Colposeptine for the Treatment of Bacterial Vaginosis
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China.
- Trial name
- NCT01153958
- Testing
- Colposeptine, Metronidazole
- Where
- 5 sites in China
- Volunteers
- 133 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Vulvovaginal Candidiasis
Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed vulvovaginal candidiasis (VVC).
- Trial name
- EpHect (NCT05507333)
- Testing
- pHyph generation II
- Where
- 4 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- Gedea Biotech AB
Bacterial Vaginosis, Candidiasis
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come back after treatment.
- Conditions
- Bacterial Vaginosis, Candidiasis, Trichomoniasis
- Trial name
- NCT01230814
- Testing
- Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)
- Where
- 4 sites in United States, Kenya
- Volunteers
- 234 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bacterial Vaginosis
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
- Trial name
- MASH (NCT00464542)
- Testing
- Metronidazole
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Bacterial Vaginosis
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than…
- Trial name
- NCT03091777
- Testing
- GDC-229, Metronidazole Vaginal Gel 0.75%
- Where
- United States
- Volunteers
- 871 people
- Sponsor
- Balmoral Medical company
Bacterial Vaginosis, HIV Infections
Phase 2 Trial of LACTIN-V in Women at High Risk of HIV Acquisition
The purpose of this study is to assess the impact of LACTIN-V, a vaginally administered live biotherapeutic product (LBP) that contains the human L.
- Trial name
- NCT05022212
- Testing
- LACTIN-V
- Where
- South Africa
- Volunteers
- 45 people
- Sponsor
- University of California, San Francisco
Vaginal Atrophy
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01358760
- Testing
- DHEA
- Where
- 42 sites in United States, Canada
- Volunteers
- 450 people
- Sponsor
- EndoCeutics Inc.
Atrophic Vaginitis
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the…
- Trial name
- NCT03294538
- Testing
- Generic Estradiol Vaginal Cream USP, 0.01%, Estrace® Vaginal Cream USP, 0.01%, Vehicle Vaginal Cream
- Where
- 44 sites in United States
- Volunteers
- 663 people
- Sponsor
- Actavis Inc.
Bacterial Vaginoses
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks).
- Trial name
- NCT04578015
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Ohio State University
Vulvovaginitis, Yeast Infection
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
- Conditions
- Vulvovaginitis, Yeast Infection, Yeast Infection Vaginal, Candidiasis, Vulvovaginal
- Trial name
- NCT02971007
- Testing
- Oral Encochleated Amphotericin B (CAMB), Fluconazole
- Where
- 23 sites in United States
- Volunteers
- 137 people
- Sponsor
- Matinas BioPharma Nanotechnologies, Inc.
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- NCT03734991
- Testing
- Ibrexafungerp
- Where
- 25 sites in United States
- Volunteers
- 376 people
- Sponsor
- Scynexis, Inc.