Trial · NCT01039584
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
NCT01039584, Not applicable, Completed, Padagis LLC; results first posted 2013-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations. Trials, record NCT01039584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01039584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
- NCT number
- NCT01039584
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 611 participants, actual
- Lead sponsor
- Padagis LLC
- Conditions
- Vulvovaginal Candidiasis
- Interventions
- Butoconazole Nitrate Vaginal Cream, Placebo, Gynazole 1 vaginal cream
- First posted
- 2009-12-25
- Last updated
- 2023-07-12
- Results first posted
- 2013-01-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | Visit 3: Day 22-31 | 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) |
| Secondary | Clinical Cure | Visit 3: Day 22-31 | Clinical cure (clinical success) was defined as follows: 1. All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure 2. A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure) 3. The subject did not require additional vulvovaginal or systemic antifungal therapy 4. The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products |
| Secondary | Mycological Cure | Visit 3: Day 22-31 | Mycological cure was defined as a negative mycological culture (no growth) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | Visit 3: Day 22-31 | per-protocol | participants | NUMBER |
| SECONDARY | Clinical Cure | Visit 3: Day 22-31 | per-protocol | participants | NUMBER |
| SECONDARY | Mycological Cure | Visit 3: Day 22-31 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | Test Product | 73 | participants | ||
| The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | Reference Product | 73 | participants | ||
| The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | Placebo | 16 | participants | ||
| Clinical Cure | Test Product | 91 | participants | ||
| Clinical Cure | Reference Product | 92 | participants | ||
| Clinical Cure | Placebo | 32 | participants | ||
| Mycological Cure | Test Product | 83 | participants | ||
| Mycological Cure | Reference Product | 79 | participants | ||
| Mycological Cure | Placebo | 18 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Product | 246 | |
| Overall Study | STARTED | Reference Product | 243 | |
| Overall Study | STARTED | Placebo | 122 | |
| Overall Study | COMPLETED | Test Product | 143 | |
| Overall Study | COMPLETED | Reference Product | 146 | |
| Overall Study | COMPLETED | Placebo | 65 | |
| Overall Study | NOT COMPLETED | Test Product | 103 | |
| Overall Study | NOT COMPLETED | Reference Product | 97 | |
| Overall Study | NOT COMPLETED | Placebo | 57 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Product | ||
| Total, all-cause mortality | Reference Product | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Test Product | 0 | 246 |
| Total, other adverse events | Reference Product | 0 | 243 |
| Total, other adverse events | Placebo | 0 | 122 |
| Total, serious adverse events | Test Product | 0 | 246 |
| Total, serious adverse events | Reference Product | 0 | 243 |
| Total, serious adverse events | Placebo | 0 | 122 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01039584
GET https://conductscience.org/api/trials/v1/NCT01039584/registered