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Multi-Center Study of New Medications to Treat Vaginal Infections (SMART GIVES)

Primary Purpose

Vaginal Infection

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Terconazole

Metronidazole

Terconazole/metronidazole

About this trial

This is an interventional treatment trial for Vaginal Infection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
Capable of providing written informed consent or assent
Currently not menstruating and not anticipating menses during treatment
If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
Negative pregnancy test
Other criteria as identified in the protocol

Exclusion Criteria:

Other infectious causes of vulvovaginitis
Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
Nursing mother
Use of any investigational drug within 30 days of enrollment
History of hypersensitivity to any ingredient/component of the formulations
Other criteria as identified in the protocol

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Terconazole vaginal gel

Metronidazole vaginal gel

Terconazole/metronidazole vaginal gel

Arm Description

One applicator full at bedtime

Outcomes

Primary Outcome Measures

Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit

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 Outcome Measures

Cure of the BV Component of Mixed Infection

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

Cure of the VVC Component of Mixed Infection

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

Microbiologic and Mycologic Cure

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.

Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit

Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.

Number of Participants With Treatment Emergent Adverse Events

Adverse events were collected at study visits, from subject diaries and from spontaneous reports

Full Information

NCT ID

NCT02308007

First Posted

December 1, 2014

Last Updated

July 21, 2020

Sponsor

Curatek Pharmaceuticals, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02308007

Brief Title

Multi-Center Study of New Medications to Treat Vaginal Infections

Acronym

SMART GIVES

Official Title

Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Curatek Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

475 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Terconazole vaginal gel

Arm Type

Active Comparator

Arm Description

One applicator full at bedtime

Arm Title

Metronidazole vaginal gel

Arm Type

Active Comparator

Arm Description

One applicator full at bedtime

Arm Title

Terconazole/metronidazole vaginal gel

Arm Type

Active Comparator

Arm Description

One applicator full at bedtime

Intervention Type

Drug

Intervention Name(s)

Terconazole

Intervention Type

Drug

Intervention Name(s)

Metronidazole

Intervention Type

Drug

Intervention Name(s)

Terconazole/metronidazole

Primary Outcome Measure Information:

Title

Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit

Description

Time Frame