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OpenTrials
Completed

NCT Number: NCT02308007

Multi-Center Study of New Medications to Treat Vaginal Infections

The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole 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

Alabama Clinical Therapeutics, 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

Metronidazole

Drug

Terconazole/metronidazole

Drug

Primary outcomes

  1. Clinical Cure of Mixed Infection (BV and VVC) 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 of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is <20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis

Secondary outcomes

  1. Cure of the BV Component of Mixed Infection

    Time frame: 7-14 days after beginning treatment

    The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was defined as: 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is <20% clue cells

  2. Cure of the VVC Component of Mixed Infection

    Time frame: 7-14 days after beginning treatment

    The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC

  3. Microbiologic and Mycologic Cure

    Time frame: 7-14 days after beginning treatment

    The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture.

  4. 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.

  5. 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
2018
Study completion
2018
First posted
Dec 4, 2014
Registry last updated
Aug 4, 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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