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NCT02392026
Safety and Tolerability of Metronidazole Gel 1.3%
Phase 4 trial testing Metronidazole Gel in Vaginosis, Bacterial in 60 participants. Completed in 5 October 2016.
5 October 2016
Quick facts
| Lead sponsor | Insud Pharma |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 12 August 2015 |
| Primary completion | 5 October 2016 |
| Estimated completion | 5 October 2016 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Metronidazole Gel
Conditions studied
- Vaginosis, Bacterial — all drugs for Vaginosis, Bacterial →
Sponsor
Insud Pharma — full company profile →
Who can join
Adults 12 to 17, female only, with Vaginosis, Bacterial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to \<18 years for the treatment of bacterial vaginosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02392026
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Insud Pharma trials
Trials by the same sponsor.
- NCT06968481 — Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage · Phase 2 · not yet recruiting
- NCT05461573 — Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females · Phase 3 · completed
- NCT05993143 — Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50 · Phase 3 · terminated
- NCT03945513 — A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles · Phase 3 · completed
- NCT04024163 — Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease · Phase 3 · 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 NCT02392026 (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 Insud Pharma
- Last refreshed: 15 August 2023
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/NCT02392026.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing