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NCT02173184
Phase III, Randomized, Double Blind, Parallel Groups, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of the Lactobacillus Vaccine Gynevac, in the Treatment of Bacterial Vaginosis
Phase 3 trial testing Gynevac in Bacterial Vaginosis in 240 participants. Status unknown.
1 April 2015
Quick facts
| Lead sponsor | Amvac Kft. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 June 2014 |
| Primary completion | 1 April 2015 |
| Estimated completion | 1 July 2015 |
| Sites | 8 locations across Hungary |
Drugs / interventions tested
- Gynevac — full drug profile →
- Placebo
Conditions studied
- Bacterial Vaginosis — all drugs for Bacterial Vaginosis →
Sponsor
Amvac Kft. — full company profile →
Who can join
Adults 18 to 55, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Therapeutic response
Time frame: 3 weeks from the time of last vaccine administration (+3 days maximum)
The percentage of patients with remission according to Amsel's criteria at week 7: resolution of the clinical findings assessed at baseline, and remission according to Gram stain Nugent score: score \< 4 or 4 to 6 with no presence of clue cells at week 7.
Sponsor's own description
To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02173184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bacterial Vaginosis
Currently open trials in the same condition.
- NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections · NA · recruiting
- NCT06458543 — Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age · Phase 4 · recruiting
- NCT06263465 — Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis · NA · recruiting
- NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome · EARLY_PHASE1 · recruiting
- NCT06616168 — Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02173184 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amvac Kft.
- Last refreshed: 28 October 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02173184.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing