Trial · NCT02308007
Multi-Center Study of New Medications to Treat Vaginal Infections
NCT02308007, Phase 3, Completed, Curatek Pharmaceuticals, LLC; results first posted 2020-08-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Multi-Center Study of New Medications to Treat Vaginal Infections. Trials, record NCT02308007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02308007
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
- NCT02308007
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 475 participants, actual
- Lead sponsor
- Curatek Pharmaceuticals, LLC
- Conditions
- Vaginal Infection
- Interventions
- Terconazole, Metronidazole, Terconazole/metronidazole
- First posted
- 2014-12-04
- Last updated
- 2020-08-04
- Results first posted
- 2020-08-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | 7-14 days after beginning treatment | The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is \<20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis |
| Secondary | Cure of the BV Component of Mixed Infection | 7-14 days after beginning treatment | The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was defined as: 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \<20% clue cells |
| Secondary | Cure of the VVC Component of Mixed Infection | 7-14 days after beginning treatment | The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC |
| Secondary | Microbiologic and Mycologic Cure | 7-14 days after beginning treatment | The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture. |
| 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
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | 7-14 days after beginning treatment | mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cure of the BV Component of Mixed Infection | 7-14 days after beginning treatment | mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cure of the VVC Component of Mixed Infection | 7-14 days after beginning treatment | mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Microbiologic and Mycologic Cure | 7-14 days after beginning treatment | mITT population (Baseline Nugent Gram stain score of 4 or more, and 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 (Baseline Nugent Gram stain score of 4 or more, and 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) | Safety population, defined as all subjects randomized to treatment and administered at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | Terconazole Vaginal Gel | 31 | Participants | ||
| Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | Metronidazole Vaginal Gel | 29 | Participants | ||
| Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit | Terconazole/Metronidazole Vaginal Gel | 43 | Participants | ||
| Cure of the BV Component of Mixed Infection | Terconazole Vaginal Gel | 38 | Participants | ||
| Cure of the BV Component of Mixed Infection | Metronidazole Vaginal Gel | 46 | Participants | ||
| Cure of the BV Component of Mixed Infection | Terconazole/Metronidazole Vaginal Gel | 54 | Participants | ||
| Cure of the VVC Component of Mixed Infection | Terconazole Vaginal Gel | 52 | Participants | ||
| Cure of the VVC Component of Mixed Infection | Metronidazole Vaginal Gel | 37 | Participants | ||
| Cure of the VVC Component of Mixed Infection | Terconazole/Metronidazole Vaginal Gel | 53 | Participants | ||
| Microbiologic and Mycologic Cure | Terconazole Vaginal Gel | 19 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terconazole Vaginal Gel | 159 | |
| Overall Study | STARTED | Metronidazole Vaginal Gel | 159 | |
| Overall Study | STARTED | Terconazole/Metronidazole Vaginal Gel | 157 | |
| Overall Study | COMPLETED | Terconazole Vaginal Gel | 83 | |
| Overall Study | COMPLETED | Metronidazole Vaginal Gel | 84 | |
| Overall Study | COMPLETED | Terconazole/Metronidazole Vaginal Gel | 82 | |
| Overall Study | NOT COMPLETED | Terconazole Vaginal Gel | 76 | |
| Overall Study | NOT COMPLETED | Metronidazole Vaginal Gel | 75 | |
| Overall Study | NOT COMPLETED | Terconazole/Metronidazole Vaginal Gel | 75 |
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 | Vulvovaginal burning sensation | Reproductive system and breast disorders | Terconazole Vaginal Gel | 5 | 149 | 5 |
| other | Vulvovaginal burning sensation | Reproductive system and breast disorders | Metronidazole Vaginal Gel | 6 | 151 | 6 |
| other | Vulvovaginal burning sensation | Reproductive system and breast disorders | Terconazole/Metronidazole Vaginal Gel | 8 | 154 | 8 |
| serious | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Terconazole Vaginal Gel | 1 | 149 | 1 |
| serious | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Metronidazole Vaginal Gel | 151 | ||
| serious | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Terconazole/Metronidazole Vaginal Gel | 154 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terconazole Vaginal Gel | 0 | 149 |
| Total, all-cause mortality | Metronidazole Vaginal Gel | 0 | 151 |
| Total, all-cause mortality | Terconazole/Metronidazole Vaginal Gel | 0 | 154 |
| Total, other adverse events | Terconazole Vaginal Gel | 5 | 149 |
| Total, other adverse events | Metronidazole Vaginal Gel | 6 | 151 |
| Total, other adverse events | Terconazole/Metronidazole Vaginal Gel | 8 | 154 |
| Total, serious adverse events | Terconazole Vaginal Gel | 1 | 149 |
| Total, serious adverse events | Metronidazole Vaginal Gel | 0 | 151 |
| Total, serious adverse events | Terconazole/Metronidazole Vaginal Gel | 0 | 154 |
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/NCT02308007
GET https://conductscience.org/api/trials/v1/NCT02308007/registered