NCT04699240

Brief Summary

We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

3.5 years

First QC Date

January 5, 2021

Last Update Submit

June 9, 2025

Conditions

Recurrent Vulvovaginal Candidiasis

Keywords

Recurrent Vulvovaginal CandidiasisLactobacillusreproductive tract flora

Outcome Measures

Primary Outcomes (1)

  • The cure rate of RVVC,

    The cure rate of RVVC,

    6 months

Secondary Outcomes (1)

  • Recurrence of RVVC

    6 months

Study Arms (2)

Clotrimazole vaginal tablets

ACTIVE COMPARATOR

Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months

Drug: clotrimazole vaginal tablets

Clotrimazole vaginal tablets+ Lactobacillus

ACTIVE COMPARATOR

Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months

Drug: Clotrimazole vaginal tablets+ Lactobacillus

Interventions

clotrimazole vaginal tabletsDRUG

Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months

Also known as: clotrimazole vaginal tablets（Bayer）
Clotrimazole vaginal tablets
Clotrimazole vaginal tablets+ LactobacillusDRUG

Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Human Reproductive Tract Active Lactobacillus,4g,qd ,3months

Also known as: Clotrimazole vaginal tablets+ Lactobacillus（Umeta-mimi）
Clotrimazole vaginal tablets+ Lactobacillus

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women be at least 18 years of age
  • Have symptoms of vulva irritation and or abnormal discharge
  • Meet the clinical criteria for RVVC
  • Willing to participate in research

You may not qualify if:

  • Taking / injecting antibiotics in the past two weeks;
  • A woman who intends to be pregnant, pregnant or lactating;
  • Long term use of contraceptives and immunosuppressants;
  • Postmenopausal;
  • There was no same fixed sexual partner (RSP) before and after treatment
  • Patients with severe gastrointestinal diseases, including colorectal cancer, IBS, IBD, chronic or acute diarrhea, long-term constipation, etc., or receiving gastrointestinal surgery and abdominal surgery within one year, such as cholecystectomy;
  • Patients with severe heart, liver and kidney dysfunction, mental diseases, infectious diseases, tumors, severe anemia, and severe autoimmune diseases (such as rheumatoid arthritis, lupus erythematosus, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Obstetrics and Gynecology

Shenzhen, Guangdong, 518036, China

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Study Officials

  • Shangrong Fan, M.D.

    Peking University Shenzhen Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

July 1, 2020

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)