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NCT01230814 · ClinicalTrials.gov registry record · Phase 2
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
A Phase 2 study of Bacterial Vaginosis and Candidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
- 4
- Study locations
NCT01230814 is a Phase 2 study of Bacterial Vaginosis and Candidiasis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 234 participants, below the 323-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (28% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT01230814, a Phase 2 study of Bacterial Vaginosis and Candidiasis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
- 4
- Study locations
Study Summary
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. Researchers want to know if using vaginal suppositories can decrease the risk of vaginal infections. Participants will include 234 women who are sexually active (greater than or equal to 4 episodes of sex with men during the past month), HIV-negative, 18 to 45 years old, with bacterial infection \[vaginosis and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis\] detected by laboratory testing at a screening visit. Women will receive vaginal suppositories containing drug or inactive ingredients (placebo). Participation in the study will be about 12 months. Study procedures include: urine and blood tests, physical exams, and questionnaires.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)
Study Locations (4)
Nairobi County
- University of Nairobi - Center for STD/HIV Research & Training - Nairobi
- University of Nairobi - Kenya AIDS Vaccine Initiative - Nairobi
Alabama
- University of Alabama at Birmingham Medical Center - Birmingham
Coast
- Women's Health Project - Ganjoni Municipal Clinic - Mombasa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01230814
The ClinicalTrials.gov registry entry for NCT01230814 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 234 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 323-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (28% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Bacterial Vaginosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01230814 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Nairobi County, Alabama, Coast.
Frequently Asked Questions
What is clinical trial NCT01230814 about?
NCT01230814 is a clinical study titled "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. Researchers want to know if using vaginal suppositories can decrease the risk of ...
What is the current status of trial NCT01230814?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2011-04. Estimated completion is 2013-08.
What conditions does trial NCT01230814 study?
This clinical trial studies the following conditions: Bacterial Vaginosis, Candidiasis, Trichomoniasis.
What interventions are being tested in trial NCT01230814?
The interventions under investigation include: Placebo (DRUG), Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate) (DRUG).
Who is sponsoring clinical trial NCT01230814?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01230814 being conducted?
This trial has 4 study locations across Alabama, Coast, Nairobi County. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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