The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis

Guangzhou Yipinhong Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Bacterial Vaginosis

Treatments: Drug: Metronidazole Tablet; Drug: Clindamycin palmitate hydrochloride dispersible tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03080740

YPH-BV

Details and patient eligibility

About

Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis

Full description

Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients clinically diagnosed with bacterial vaginosis, should meet the following criteria: vaginal Gram stain integration score (Nugent score) ≥7 points
2. Female patients aged 18 to 55 years old.
3. Patients signed the Informed Consent Form(ICF).

Exclusion criteria

1. Patients with vulvovaginitis caused by other infectional reasons such as vaginitis vulvovaginal candidiasis, trichomoniasis vaginitis.

2. Patients received systemic or vaginal antimicrobial therapy in a week before enrolled.

3. Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy.

4. Pregnant or lactating patients.

5. Menopausal women.

   Menopause definition: perimenopausal women stop menstruations for a year.

6. Women with diabetes.

7. Dependent on alcohol and could not prohibit during the study period.

8. Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases.

9. Women allergic to metronidazole, clindamycin.

10. With poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Clindamycin palmitate hydrochloride

Active Comparator group

Description:

Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days

Treatment:

Drug: Clindamycin palmitate hydrochloride dispersible tablet

Metronidazole

Active Comparator group

Description:

Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days

Treatment:

Drug: Metronidazole Tablet