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NCT01039584 · ClinicalTrials.gov registry record · NA
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
A NA study, sponsored by Padagis.
- Completed
- Registry status
- NA
- Development phase
- 611
- Enrollment target
NCT01039584: Completed NA study, sponsored by Padagis.
NCT01039584 is a NA study that has completed, run by Padagis. The registered enrollment target is 611 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01039584, a NA study, has completed, sponsored by Padagis.
- COMPLETED
- Registry status
- NA
- Development phase
- 611 participants
- Enrollment target
Study Summary
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.
Primary Outcome
Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)
Interventions
- DRUG Placebo
- DRUG Butoconazole Nitrate Vaginal Cream
- DRUG Gynazole 1 vaginal cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-12 |
| Phase | NA |
What the finished NCT01039584 record still lists
NCT01039584 is an interventional study that assigns participants to a tested intervention. The registered 611 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01039584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01039584 about?
NCT01039584 is a clinical study titled "A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations". This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.
What is the current status of trial NCT01039584?
This trial is currently completed. It is a NA study. The enrollment target is 611 participants. The study started on 2008-02. Estimated completion is 2009-12.
What interventions are being tested in trial NCT01039584?
The interventions under investigation include: Placebo (DRUG), Butoconazole Nitrate Vaginal Cream (DRUG), Gynazole 1 vaginal cream (DRUG).
Who is sponsoring clinical trial NCT01039584?
This trial is sponsored by Padagis, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01039584's enrollment target sits among peer trials
611 161st of 2000 higher than 1,840 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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