Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 22 for:    "Vulvitis" | "Steroid Synthesis Inhibitors"

Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02180100
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Shanghai Shyndec Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Shangrong Fan, Peking University Shenzhen Hospital

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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Drug: Terconazole Vaginal Suppository Drug: Fluconazole Phase 4

Detailed Description:
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
Study Start Date : August 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: Terconazole Vaginal Suppository
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Drug: Terconazole Vaginal Suppository
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Other Name: Tekangzuo Yindao Shuan

Active Comparator: Fluconazole
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Drug: Fluconazole
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Other Name: Diflucan




Primary Outcome Measures :
  1. Proportion of Subjects in Each Treatment Group With Therapeutic Cure [ Time Frame: Visit 3: Day 35-42 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180100


Locations
Layout table for location information
China, Guangdong
Peking University Shenzhen Hosptal
Shenzhen, Guangdong, China, 518036
Sponsors and Collaborators
Peking University Shenzhen Hospital
Shanghai Shyndec Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Shangrong Fan, M.D. Peking University Shenzhen Hospital

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Shangrong Fan, Prof of Obstetrics and Gynecology, Peking University Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT02180100     History of Changes
Other Study ID Numbers: PKUSH-GNY-2013-01
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Vulvitis
Steroid Synthesis Inhibitors
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvar Diseases
Fluconazole
Terconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors