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NCT05211921
Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
NA trial testing Multi-Gyn ActiGel Plus in Bacterial Vaginosis in 50 participants. Completed in 11 May 2022.
11 May 2022
Quick facts
| Lead sponsor | Karo Pharma AB |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 7 December 2021 |
| Primary completion | 11 May 2022 |
| Estimated completion | 11 May 2022 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Multi-Gyn ActiGel Plus
Conditions studied
- Bacterial Vaginosis — all drugs for Bacterial Vaginosis →
Sponsor
Karo Pharma AB
Who can join
18 and older, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.
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 NCT05211921
- 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
Other Karo Pharma AB trials
Trials by the same sponsor.
- NCT07233473 — Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections · NA · recruiting
- NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections · NA · recruiting
- NCT05552378 — Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms · NA · completed
- NCT05732337 — Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device. · NA · completed
- NCT05560841 — Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis · NA · completed
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 NCT05211921 (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 Karo Pharma AB
- Last refreshed: 18 August 2022
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/NCT05211921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing