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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: Completed Phase 2 study of Bacterial Vaginosis and Candidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar.
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 |
What the finished NCT01230814 record still lists
NCT01230814 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (28% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01230814's enrollment target sits among peer trials
234 8th of 15 higher than 8 of 15 other Bacterial Vaginosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Vaginosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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