Trial · NCT02308033

Multi-Center Study of New Medications to Treat Vaginal Infections

NCT02308033, 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 NCT02308033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02308033

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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: NCT02308033
Status: Completed
Phases: Phase 3
Enrollment: 204 participants, actual
Lead sponsor: Curatek Pharmaceuticals, LLC
Conditions: Vaginal Infection
Interventions: Metronidazole, Gel vehicle
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. Clinical cure of bacterial vaginosis is 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	Improvement of BV Clue Cells	7-14 days after beginning treatment	Clue cells on wet mount were assessed and categorized as absent (\<20%) or present (\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\<20%).
Secondary	Microbiologic Improvement/Cure	7-14 days after beginning treatment	For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.
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 (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Improvement of BV Clue Cells	7-14 days after beginning treatment	mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Microbiologic Improvement/Cure	7-14 days after beginning treatment	mITT population (Baseline Gram stain Nugent score of 4 or more 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 Gram stain Nugent score of 4 or more 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	Units
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit	Metronidazole Vaginal Gel		47	Participants
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit	Gel Vehicle		18	Participants
Improvement of BV Clue Cells	Metronidazole Vaginal Gel	Clue cells absent	52	Participants
Improvement of BV Clue Cells	Gel Vehicle	Clue cells absent	19	Participants
Improvement of BV Clue Cells	Metronidazole Vaginal Gel	Clue cells present	17	Participants
Improvement of BV Clue Cells	Gel Vehicle	Clue cells present	58	Participants
Improvement of BV Clue Cells	Metronidazole Vaginal Gel	Data missing	7	Participants
Improvement of BV Clue Cells	Gel Vehicle	Data missing	6	Participants
Microbiologic Improvement/Cure	Metronidazole Vaginal Gel	Normal Nugent score	38	Participants
Microbiologic Improvement/Cure	Gel Vehicle	Normal Nugent score	7	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metronidazole Vaginal Gel	102
Overall Study	STARTED	Gel Vehicle	102
Overall Study	COMPLETED	Metronidazole Vaginal Gel	76
Overall Study	COMPLETED	Gel Vehicle	83
Overall Study	NOT COMPLETED	Metronidazole Vaginal Gel	26
Overall Study	NOT COMPLETED	Gel Vehicle	19

Source ClinicalTrials.gov

Adverse events8

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 pruritis	Reproductive system and breast disorders	Metronidazole Vaginal Gel	8	96	8
other	Vulvovaginal pruritis	Reproductive system and breast disorders	Gel Vehicle	6	97	6
other	Vulvovaginal candidiasis	Infections and infestations	Metronidazole Vaginal Gel	7	96	7
other	Vulvovaginal candidiasis	Infections and infestations	Gel Vehicle	1	97	1
other	Vulvovaginal mycotic infection	Infections and infestations	Metronidazole Vaginal Gel	5	96	5
other	Vulvovaginal mycotic infection	Infections and infestations	Gel Vehicle	1	97	1
other	Headache	Nervous system disorders	Metronidazole Vaginal Gel	5	96	5
other	Headache	Nervous system disorders	Gel Vehicle	2	97	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metronidazole Vaginal Gel	0	96
Total, all-cause mortality	Gel Vehicle	0	97
Total, other adverse events	Metronidazole Vaginal Gel	25	96
Total, other adverse events	Gel Vehicle	10	97
Total, serious adverse events	Metronidazole Vaginal Gel	0	96
Total, serious adverse events	Gel Vehicle	0	97

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
Metronidazole Vaginal Gel vs Gel Vehicle: Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit	Trial comparisons
Metronidazole Vaginal Gel vs Gel Vehicle: Number of Participants With Treatment Emergent Adverse Events	Trial comparisons
Metronidazole Vaginal Gel vs Gel Vehicle: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit	Trial comparisons
Metronidazole Vaginal Gel vs Gel Vehicle: deaths from any cause	Trial comparisons
Metronidazole 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02308033

GET https://conductscience.org/api/trials/v1/NCT02308033/registered

API reference For AI assistants