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Completed

NCT Number: NCT00803738

Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female at least 18 years of age
  • Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
  • Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.

Exclusion criteria

  • History of hypersensitivity or allergy to imidazoles
  • Female who was pregnant or lactating
  • Was menstruating or expected the onset of menses during the treatment days
  • Had evidence of any bacterial, viral or protozoal infection
  • Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
  • Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
  • Had participated in any investigational study within 30 days prior to study enrollment

Treatment and study plan

Terconazole Vaginal Suppository

Drug

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Terazol Vaginal Suppository

Drug

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Other names: Terazol 3 suppository

Primary outcomes

  1. Proportion of Subjects in Each Treatment Group With Therapeutic Cure

    Time frame: Visit 3: Day 22-31

    The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.

Secondary outcomes

  1. Proportion of Subjects With Mycological Cure

    Time frame: Visit 3: Day 22-31

    Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.

  2. Proportion of Subjects With Clinical Cure

    Time frame: Visit 3: Day 22-31

    A subject was considered a clinical cure if all of the following were satisfied:

    • All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.
    • Total signs and symptoms did not worsen at any time following completion of the study treatment.
    • Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.
    • The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.
    • The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Official study title

A Multi-center, Randomized, Investigator-blinded, Parallel-group Study, Designed to Evaluate the Safety and Clinical Equivalence of Terconazole Vaginal Suppositories, 80 mg (Test Product) and Terconazole Vaginal Suppositories, 80 mg (Reference Product) in the Treatment of Vulvovaginal Candidiasis Caused by Candida Species

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Dec 8, 2008
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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