NCT00755053

Brief Summary

The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
466

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_3

Geographic Reach
2 countries

17 active sites

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

September 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 6, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

September 17, 2008

Last Update Submit

August 4, 2015

Conditions

ClotrimazoleOvulenVulvovaginal Candidiasis

Keywords

ClotrimazoleOvuleTabletVulvovaginal candidiasisNon-inferiority

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)

    10-14 days after treatment (=visit 2)

Secondary Outcomes (5)

  • Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)

    6-8 weeks after treatment (=visit 3)

  • Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)

    10-14 days after treatment (=visit 2)

  • Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)

    6-8 weeks after treatment (=visit 3)

  • Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)

    10-14 days after treatment (=visit 2)

  • Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)

    6-8 weeks after treatment (=visit 3)

Study Arms (2)

Clotrimazole tablet (Canesten, BAY-B5097)

ACTIVE COMPARATOR

Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

Drug: Clotrimazole, vaginal tablet

Clotrimazole ovule (Canesten, BAY-B5097)

EXPERIMENTAL

Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

Drug: Clotrimazole, vaginal ovule

Interventions

Clotrimazole, vaginal ovuleDRUG

Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).

Clotrimazole ovule (Canesten, BAY-B5097)
Clotrimazole, vaginal tabletDRUG

Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).

Clotrimazole tablet (Canesten, BAY-B5097)

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
  • Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
  • Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
  • Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
  • Negative saline smear for Trichomonas vaginalis

You may not qualify if:

  • Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
  • Subjects presenting a protozoan infection as confirmed by microscopic investigation.
  • Pregnant, breast feeding or lactating subjects.
  • Subjects with suspected bacterial vaginal infection.
  • Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
  • Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1.
  • Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.
  • Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).
  • Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).
  • Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).
  • Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.
  • Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.
  • Subjects who received another investigational drug within 30 days before visit 1.
  • Unwillingness to refrain from sexual activity during 3 days thereafter.
  • Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Unknown Facility

München, Bavaria, 80333, Germany

Location

Unknown Facility

München, Bavaria, 85356, Germany

Location

Unknown Facility

Hamburg, Hamburg, 22159, Germany

Location

Unknown Facility

Hamburg, Hamburg, 22359, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 65929, Germany

Location

Unknown Facility

Fulda, Hesse, 36037, Germany

Location

Unknown Facility

Wiesbaden, Hesse, 65197, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30459, Germany

Location

Unknown Facility

Osnabrück, Lower Saxony, 49074, Germany

Location

Unknown Facility

Dortmund, North Rhine-Westphalia, 44319, Germany

Location

Unknown Facility

Krefeld, North Rhine-Westphalia, 47799, Germany

Location

Unknown Facility

Moscow, 117198, Russia

Location

Unknown Facility

Moscow, 119002, Russia

Location

Unknown Facility

Moscow, 119049, Russia

Location

Unknown Facility

Moscow, 127473, Russia

Location

Unknown Facility

Moscow, 129090, Russia

Location

Related Links

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

ClotrimazoleVaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 6, 2015

Record last verified: 2015-07

Locations

DE(12)RU(5)