drugset / Trial / NCT03446443
Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Phase 4
Unknown
240 enrolled
Dongfang Hospital Beijing University of Chinese Medicine
Beijing Compete Pharmaceutical Co., Ltd. · collabPeking University First Hospital · collabShandong Buchang Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a Randomized, Positive -Controlled, Multi-center Trial enrolling 240 subjects with Bacterial Vaginosis who will be randomized at a ratio of 1:1 to receive active Honghe Fujie lotion or Metronidazole Suppositories. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.
Timeline
- Start
- 2018-07-26
- Primary completion
- 2019-07-31
- Completion
- 2020-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Honghe Fujie lotion | Unknown | 10 ml | Other |
| Comparator | Metronidazole | Small molecule | 0.5 g | Other |