Trial · NCT02180828
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
NCT02180828, Phase 4, Completed, Peking University Shenzhen Hospital; results first posted 2016-09-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis. Trials, record NCT02180828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02180828
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
- NCT number
- NCT02180828
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 240 participants, actual
- Lead sponsor
- Peking University Shenzhen Hospital
- Conditions
- Candidiasis, Vulvovaginal
- Interventions
- Clotrimazole vaginal tablet, Fluconazole
- First posted
- 2014-07-03
- Last updated
- 2017-05-02
- Results first posted
- 2016-09-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Therapeutic Efficacy 1 | 7-14 days after treatment (=visit 2) | The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures. |
| Primary | Therapeutic Efficacy 2 | at days 30-35 follow-up | The clinical cure rates of clotrimazole and fluconazol |
| Primary | Therapeutic Efficacy 3 | at days 7-14 follow-up | Mycological cure of clotrimazole group and fluconazole group |
| Primary | Therapeutic Efficacy 4 | at days30-35 follow-up | Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits. |
| Secondary | Adverse Events 1 | at day 7-14 follow up | Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue. |
| Secondary | Adverse Events 2 | at day 7-14 follow up | Vulvovaginal pruritus, burning, irritation, and bleeding |
| Secondary | Adverse Events 3 | at day 7-14 follow up | Gastrointestinal tract: abdominal pain, diarrhoea, nausea |
| Secondary | Adverse Events 4 | at day 7-14 follow up | Skin sensitivity, urticaria rash, erythematous rash, irritation |
| Secondary | Total Adverse Events | at day 7-14 follow up | Total adverse events(cases) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Therapeutic Efficacy 1 | 7-14 days after treatment (=visit 2) | PPS | participants | NUMBER |
| PRIMARY | Therapeutic Efficacy 2 | at days 30-35 follow-up | participants | NUMBER | |
| PRIMARY | Therapeutic Efficacy 3 | at days 7-14 follow-up | participants | NUMBER | |
| PRIMARY | Therapeutic Efficacy 4 | at days30-35 follow-up | participants | NUMBER | |
| SECONDARY | Adverse Events 1 | at day 7-14 follow up | participants | NUMBER | |
| SECONDARY | Adverse Events 2 | at day 7-14 follow up | participants | NUMBER | |
| SECONDARY | Adverse Events 3 | at day 7-14 follow up | participants | NUMBER | |
| SECONDARY | Adverse Events 4 | at day 7-14 follow up | participants | NUMBER | |
| SECONDARY | Total Adverse Events | at day 7-14 follow up | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Therapeutic Efficacy 1 | Clotrimazole Vaginal Tablet | 102 | participants | ||
| Therapeutic Efficacy 1 | Fluconazole | 98 | participants | ||
| Therapeutic Efficacy 2 | Clotrimazole Vaginal Tablet | 82 | participants | ||
| Therapeutic Efficacy 2 | Fluconazole | 85 | participants | ||
| Therapeutic Efficacy 3 | Clotrimazole Vaginal Tablet | 90 | participants | ||
| Therapeutic Efficacy 3 | Fluconazole | 81 | participants | ||
| Therapeutic Efficacy 4 | Clotrimazole Vaginal Tablet | 62 | participants | ||
| Therapeutic Efficacy 4 | Fluconazole | 61 | participants | ||
| Adverse Events 1 | Clotrimazole Vaginal Tablet | 1 | participants | ||
| Adverse Events 1 | Fluconazole | 9 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clotrimazole Vaginal Tablet | 120 | |
| Overall Study | STARTED | Fluconazole | 120 | |
| Overall Study | COMPLETED | Clotrimazole Vaginal Tablet | 115 | |
| Overall Study | COMPLETED | Fluconazole | 113 | |
| Overall Study | NOT COMPLETED | Clotrimazole Vaginal Tablet | 5 | |
| Overall Study | NOT COMPLETED | Fluconazole | 7 |
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 | Systemic | Cardiac disorders | Clotrimazole Vaginal Tablet | 1 | 115 | 1 |
| other | Systemic | Cardiac disorders | Fluconazole | 9 | 113 | 9 |
| other | Vulvovaginal | Reproductive system and breast disorders | Clotrimazole Vaginal Tablet | 12 | 115 | 12 |
| other | Vulvovaginal | Reproductive system and breast disorders | Fluconazole | 1 | 113 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clotrimazole Vaginal Tablet | ||
| Total, all-cause mortality | Fluconazole | ||
| Total, other adverse events | Clotrimazole Vaginal Tablet | 13 | 115 |
| Total, other adverse events | Fluconazole | 10 | 113 |
| Total, serious adverse events | Clotrimazole Vaginal Tablet | 0 | 115 |
| Total, serious adverse events | Fluconazole | 0 | 113 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27073145 | RESULT |
Source PubMed
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Clotrimazole Vaginal Tablet vs Fluconazole: Adverse Events 3 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Therapeutic Efficacy 1 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Therapeutic Efficacy 2 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Adverse Events 4 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Therapeutic Efficacy 4 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Therapeutic Efficacy 3 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Total Adverse Events | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Adverse Events 2 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: Adverse Events 1 | Trial comparisons |
| Clotrimazole Vaginal Tablet vs Fluconazole: 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/NCT02180828
GET https://conductscience.org/api/trials/v1/NCT02180828/registered