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OpenTrials
Completed

NCT Number: NCT02308046

Multi-Center Study of New Medications to Treat Vaginal Infections

The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections

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Key information

Conditions

Vaginal Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Age range

12 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
  • Capable of providing written informed consent or assent
  • Currently not menstruating and not anticipating menses during treatment
  • If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
  • Negative pregnancy test
  • Other criteria as identified in the protocol

Exclusion criteria

  • Other infectious causes of vulvovaginitis
  • Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
  • Nursing mother
  • Use of any investigational drug within 30 days of enrollment
  • History of hypersensitivity to any ingredient/component of the formulations
  • Other criteria as identified in the protocol

Treatment and study plan

Terconazole

Drug

Placebo

Drug

Primary outcomes

  1. Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit

    Time frame: 7-14 days after beginning treatment

    The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis

Secondary outcomes

  1. Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection

    Time frame: 7-14 days after beginning treatment

    Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement.

  2. Mycologic Cure

    Time frame: 7-14 days after beginning treatment and at 21-30 days after beginning treatment

    Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure.

  3. Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit

    Time frame: 7-14 days after beginning treatment

    Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.

  4. Number of Participants With Treatment Emergent Adverse Events

    Time frame: Any time during study participation (up to 30 days)

    Adverse events were collected at study visits, from subject diaries and from spontaneous reports

Sponsors and collaborators

Lead sponsor

Curatek Pharmaceuticals, LLC

Industry

Registry information

Official study title

Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety

Acronym: SMART GIVES

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 4, 2014
Registry last updated
Jul 27, 2020

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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