NCT02180100

Brief Summary

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

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 Aug 2013

Shorter than P25 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

August 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

October 23, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

June 30, 2014

Results QC Date

August 20, 2019

Last Update Submit

October 22, 2020

Conditions

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

  • Mycological Cure 1

    Based on candida culture

    Between day 7-14 after treatment, an average of 10 days

Secondary Outcomes (1)

  • Mycological Cure 2

    Between day 28-35 after treatment, an average of 30 days

Study Arms (2)

Terconazole Vaginal Suppository

EXPERIMENTAL

Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days

Drug: Terconazole Vaginal Suppository

Fluconazole

ACTIVE COMPARATOR

orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Drug: Fluconazole

Interventions

Terconazole Vaginal SuppositoryDRUG

Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days

Also known as: Tekangzuo Yindao Shuan
Terconazole Vaginal Suppository
FluconazoleDRUG

orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Also known as: Diflucan
Fluconazole

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
  • Subject completes the informed consent process
  • Subject agrees to take study medication when scheduled
  • Subject complies with all clinical trial instructions. Commits to all follow-up visits
  • Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment

You may not qualify if:

  • had any other sexually transmitted disease or gynaecological abnormality requiring treatment
  • had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
  • had used antifungal medication in the week before entry; or
  • were expected to menstruate within seven days of the start of treatment
  • infected more than one candida species

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Shenzhen Hosptal

Shenzhen, Guangdong, 518036, China

Location

Related Publications (1)

  • Li T, Zhu Y, Fan S, Liu X, Xu H, Liang Y. A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis. Med Mycol. 2015 Jun;53(5):455-61. doi: 10.1093/mmy/myv017. Epub 2015 Apr 15.

    PMID: 25877666RESULT

Related Links

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Prof. Shangrong Fan
Organization
Peking University Shenzhen Hospital
fanshangrong@163.com
86755-83923333

Study Officials

  • Shangrong Fan, M.D.

    Peking University Shenzhen Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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
Prof of Obstetrics and Gynecology

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 2, 2014

Study Start

August 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 23, 2020

Results First Posted

October 23, 2020

Record last verified: 2020-10

Locations

CN(1)