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OpenTrials
Completed

NCT Number: NCT02308033

Multi-Center Study of New Medications to Treat Vaginal Infections

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

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

Metronidazole

Drug

Gel Vehicle

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. Clinical cure of bacterial vaginosis is 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

Secondary outcomes

  1. Improvement of BV Clue Cells

    Time frame: 7-14 days after beginning treatment

    Clue cells on wet mount were assessed and categorized as absent (<20%) or present (>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (<20%).

  2. Microbiologic Improvement/Cure

    Time frame: 7-14 days after beginning treatment

    For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.

  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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