Phase 3
Completed N=475
Multi-Center Study of New Medications to Treat Vaginal Infections
Vaginal Infection
Source: ClinicalTrials.gov NCT02308007 ↗
Enrolled (actual)
475
Serious AEs
0.2%
Results posted
Aug 2020
Primary outcomePrimary: Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit — 31; 29; 43 Participants — p=0.030
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit |
31; 29; 43 | 0.030 sig |
| SECONDARY Cure of the BV Component of Mixed Infection |
38; 46; 54 | 0.015 sig |
| SECONDARY Cure of the VVC Component of Mixed Infection |
52; 37; 53 | 0.012 sig |
| SECONDARY Microbiologic and Mycologic Cure |
19; 5; 24 | — |
| SECONDARY Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit |
49; 44; 49 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
44; 40; 44 | — |
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 (NCT02308007). 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. Informational only — not medical advice.