Trial · NCT02308046
Multi-Center Study of New Medications to Treat Vaginal Infections
NCT02308046, Phase 3, Completed, Curatek Pharmaceuticals, LLC; results first posted 2020-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multi-Center Study of New Medications to Treat Vaginal Infections. Trials, record NCT02308046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02308046
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-Center Study of New Medications to Treat Vaginal Infections
- NCT number
- NCT02308046
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 212 participants, actual
- Lead sponsor
- Curatek Pharmaceuticals, LLC
- Conditions
- Vaginal Infection
- Interventions
- Terconazole, Placebo
- First posted
- 2014-12-04
- Last updated
- 2020-07-27
- Results first posted
- 2020-07-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | 7-14 days after beginning treatment | The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis |
| Secondary | Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | 7-14 days after beginning treatment | Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement. |
| Secondary | Mycologic Cure | 7-14 days after beginning treatment and at 21-30 days after beginning treatment | Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure. |
| Secondary | Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | 7-14 days after beginning treatment | Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Any time during study participation (up to 30 days) | Adverse events were collected at study visits, from subject diaries and from spontaneous reports |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | 7-14 days after beginning treatment | mITT population (positive baseline yeast culture and used at least one dose of study medication) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | 7-14 days after beginning treatment | mITT population (positive baseline yeast culture and used at least one dose of study medication) | score on a scale | MEDIAN |
| SECONDARY | Mycologic Cure | 7-14 days after beginning treatment and at 21-30 days after beginning treatment | mITT population (positive baseline yeast culture and used at least one dose of study medication) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | 7-14 days after beginning treatment | mITT population (positive baseline yeast culture and used at least one dose of study medication) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | Any time during study participation (up to 30 days) | The safety population includes all subjects randomized to treatment and administered at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | Terconazole Vaginal Gel | 47 | Participants | ||
| Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | Gel Vehicle | 25 | Participants | ||
| Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | Terconazole Vaginal Gel | 0.0 | Full Range 0 to 18 | score on a scale | |
| Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | Gel Vehicle | 3.0 | Full Range 0 to 18 | score on a scale | |
| Mycologic Cure | Terconazole Vaginal Gel | Candida culture cure at 7-14 days / Candia culture negative | 57 | Participants | |
| Mycologic Cure | Gel Vehicle | Candida culture cure at 7-14 days / Candia culture negative | 6 | Participants | |
| Mycologic Cure | Terconazole Vaginal Gel | Candida culture cure at 7-14 days / Candida culture positive | 13 | Participants | |
| Mycologic Cure | Gel Vehicle | Candida culture cure at 7-14 days / Candida culture positive | 54 | Participants | |
| Mycologic Cure | Terconazole Vaginal Gel | Candida culture cure at 7-14 days / Culture not taken | 3 | Participants | |
| Mycologic Cure | Gel Vehicle | Candida culture cure at 7-14 days / Culture not taken | 7 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terconazole Vaginal Gel | 107 | |
| Overall Study | STARTED | Gel Vehicle | 105 | |
| Overall Study | COMPLETED | Terconazole Vaginal Gel | 73 | |
| Overall Study | COMPLETED | Gel Vehicle | 67 | |
| Overall Study | NOT COMPLETED | Terconazole Vaginal Gel | 34 | |
| Overall Study | NOT COMPLETED | Gel Vehicle | 38 |
Source ClinicalTrials.gov
Adverse events4
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 | Vulvovaginal burning sensation | Reproductive system and breast disorders | Terconazole Vaginal Gel | 7 | 102 | 7 |
| other | Vulvovaginal burning sensation | Reproductive system and breast disorders | Gel Vehicle | 2 | 99 | 2 |
| other | Bacterial vaginosis | Infections and infestations | Terconazole Vaginal Gel | 9 | 102 | 9 |
| other | Bacterial vaginosis | Infections and infestations | Gel Vehicle | 12 | 99 | 12 |
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 Gel | 0 | 102 |
| Total, all-cause mortality | Gel Vehicle | 0 | 99 |
| Total, other adverse events | Terconazole Vaginal Gel | 16 | 102 |
| Total, other adverse events | Gel Vehicle | 14 | 99 |
| Total, serious adverse events | Terconazole Vaginal Gel | 0 | 102 |
| Total, serious adverse events | Gel Vehicle | 0 | 99 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Terconazole Vaginal Gel vs Gel Vehicle: Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | Trial comparisons |
| Terconazole Vaginal Gel vs Gel Vehicle: Number of Participants With Treatment Emergent Adverse Events | Trial comparisons |
| Terconazole Vaginal Gel vs Gel Vehicle: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | Trial comparisons |
| Terconazole Vaginal Gel vs Gel Vehicle: deaths from any cause | Trial comparisons |
| Terconazole Vaginal Gel vs Gel Vehicle: 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/NCT02308046
GET https://conductscience.org/api/trials/v1/NCT02308046/registered