NCT03357666

Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis

A Double-blind, Randomized, Placebo-controlled, Parallel Design, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of HUDC_VT in Patients With Bacterial Vaginosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Haudongchun Co., Ltd. · Industry
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after HUDC-VT administration compared to placebo in patients with bacterial vaginosis. Vaginitis in adult women is extremely common and it often results in marked suffering. Epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in US. The broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.However, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus. In addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina. The product, HUDC\_VT, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.

Conditions

• Bacterial Vaginosis
• HUDC_VT
• Haudongchun

Interventions

Type	Name	Description
DRUG	HUDC_VT(Glucose 200mg/Sodium chloride 200mg)	Vaginal administration, two tablets once a day for 7 days
DRUG	HUDC_VT (Glucose 400mg/Sodium chloride 200mg)	Vaginal administration, two tablets once a day for 7 days
DRUG	HUDC_VT (Glucose 400mg)	Vaginal administration, two tablets once a day for 7 days
DRUG	HUDC_VT (Sodium chloride 200mg)	Vaginal administration, two tablets once a day for 7 days
DRUG	Placebo	Vaginal administration, two tablets once a day for 7 days

Timeline

• Start date: 2016-03-22
• Primary completion: 2018-03-01
• Completion: 2018-03-30
• First posted: 2017-11-30
• Last updated: 2017-12-02

Locations

1 site across 1 country: South Korea