Clinical trial NCT03080740: The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis
Official title: The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bacterial Vaginosis
Lead sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
Sponsor class: INDUSTRY
First posted: 2017-03-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Nugent score
timeFrame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
Secondary outcomes:
measure: The pH of vaginal secretions;
timeFrame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
measure: Leucorrhea routine examination
timeFrame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
measure: Itching score
timeFrame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
measure: Vaginal secretions
timeFrame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University first hospital
Study officials:
affiliation: Peking University First Hospital
name: Zhaohui Liu, MD
role: STUDY_CHAIR
affiliation: Peking University Shenzhen Hospital
name: Shangrong Fan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Gynecology and Obstetrics Hospital of Fudan University
name: Long Sui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xi 'an Jiaotong University
name: Ruifang An, MD
role: PRINCIPAL_INVESTIGATOR
References: