Trial · NCT00803738
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
NCT00803738, Not applicable, Completed, Padagis LLC; results first posted 2013-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis. Trials, record NCT00803738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00803738
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
- NCT number
- NCT00803738
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 572 participants, actual
- Lead sponsor
- Padagis LLC
- Conditions
- Vulvovaginal Candidiasis
- Interventions
- Terconazole Vaginal Suppository, Terazol Vaginal Suppository
- First posted
- 2008-12-08
- Last updated
- 2021-10-13
- Results first posted
- 2013-02-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects in Each Treatment Group With Therapeutic Cure | Visit 3: Day 22-31 | The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure. |
| Secondary | Proportion of Subjects With Mycological Cure | Visit 3: Day 22-31 | Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism. |
| Secondary | Proportion of Subjects With Clinical Cure | Visit 3: Day 22-31 | A subject was considered a clinical cure if all of the following were satisfied: 1. All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1. 2. Total signs and symptoms did not worsen at any time following completion of the study treatment. 3. Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC. 4. The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period. 5. 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 analgesic or corticosteroid products |
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 | Proportion of Subjects in Each Treatment Group With Therapeutic Cure | Visit 3: Day 22-31 | Per Protocol (PP) population | participants | NUMBER |
| SECONDARY | Proportion of Subjects With Mycological Cure | Visit 3: Day 22-31 | Per protocol population | participants | NUMBER |
| SECONDARY | Proportion of Subjects With Clinical Cure | Visit 3: Day 22-31 | per protocol population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects in Each Treatment Group With Therapeutic Cure | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 105 | -4.3 to 15.02 | participants | |
| Proportion of Subjects in Each Treatment Group With Therapeutic Cure | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 93 | -4.3 to 15.02 | participants | |
| Proportion of Subjects With Mycological Cure | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 127 | participants | ||
| Proportion of Subjects With Mycological Cure | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 117 | participants | ||
| Proportion of Subjects With Clinical Cure | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 117 | participants | ||
| Proportion of Subjects With Clinical Cure | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 101 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 286 | |
| Overall Study | STARTED | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 286 | |
| Overall Study | COMPLETED | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 192 | |
| Overall Study | COMPLETED | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 176 | |
| Overall Study | NOT COMPLETED | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 94 | |
| Overall Study | NOT COMPLETED | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 110 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | headache | Nervous system disorders | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 36 | 282 | 36 |
| other | headache | Nervous system disorders | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 39 | 275 | 39 |
| other | infection | Infections and infestations | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 12 | 282 | 12 |
| other | infection | Infections and infestations | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 15 | 275 | 15 |
| serious | appendicitis | Infections and infestations | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 0 | 282 | 0 |
| serious | appendicitis | Infections and infestations | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 1 | 275 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terconazole Vaginal Suppositories, 80 mg - Perrigo | ||
| Total, all-cause mortality | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | ||
| Total, other adverse events | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 48 | 282 |
| Total, other adverse events | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 54 | 275 |
| Total, serious adverse events | Terconazole Vaginal Suppositories, 80 mg - Perrigo | 0 | 282 |
| Total, serious adverse events | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | 1 | 275 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Terconazole Vaginal Suppositories, 80 mg - Perrigo vs Terazol 3 - Terconazole Vaginal Suppositories 80 mg: Proportion of Subjects With Clinical Cure | Trial comparisons |
| Terconazole Vaginal Suppositories, 80 mg - Perrigo vs Terazol 3 - Terconazole Vaginal Suppositories 80 mg: Proportion of Subjects With Mycological Cure | Trial comparisons |
| Terconazole Vaginal Suppositories, 80 mg - Perrigo vs Terazol 3 - Terconazole Vaginal Suppositories 80 mg: Proportion of Subjects in Each Treatment Group With Therapeutic Cure | Trial comparisons |
| Terconazole Vaginal Suppositories, 80 mg - Perrigo vs Terazol 3 - Terconazole Vaginal Suppositories 80 mg: serious adverse events | Trial comparisons |
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/NCT00803738
GET https://conductscience.org/api/trials/v1/NCT00803738/registered