Phase 3
N=204
Multi-Center Study of New Medications to Treat Vaginal Infections
Vaginal Infection
Bottom Line
View on ClinicalTrials.gov: NCT02308033 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit — 47; 18 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metronidazole (Drug); Gel vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Curatek Pharmaceuticals, LLC
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit |
47; 18 | <0.001 sig |
| SECONDARY Improvement of BV Clue Cells |
52; 19; 17; 58; 7; 6 | <0.001 sig |
| SECONDARY Microbiologic Improvement/Cure |
38; 7; 16; 11; 15; 59 | <0.001 sig |
| SECONDARY Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit |
43; 32 | 0.034 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
42; 31 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02308033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.