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Trial record 1 of 3 for:    Bacterial Vaginosis | Sweden
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Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762083
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Gedea Biotech AB

Tracking Information
First Submitted Date  ICMJE November 30, 2018
First Posted Date  ICMJE December 3, 2018
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE January 7, 2019
Actual Primary Completion Date October 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
Clinical cure rate [ Time Frame: Day 7 ]
Defined as absence of all of the following 3 Amsel criteria:
  1. Thin, white, yellow, homogenous discharge
  2. Clue cells on microscopy (more than 20% of epithelial cells)
  3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2018)
  • Proportion of patients being negative for each of the 3 Amsel criteria [ Time Frame: Day 7 compared to Day 0 ]
    Defined as absence of the following Amsel criteria:
    1. Thin, white, yellow, homogenous discharge
    2. Clue cells on microscopy (more than 20% of epithelial cells)
    3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
  • Usability, measured by patient questionnaire [ Time Frame: Day 7 ]
    General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]
  • Proportion of patients having a recurrence of the BV [ Time Frame: Up to day 42 ]
    Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • Proportion of patients being negative for each of the 3 Amsel criteria [ Time Frame: Day 7 compared to Day 0 ]
    Amsel criteria defined as above
  • Usability, measured by patient questionnaire [ Time Frame: Day 7 ]
    General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]
  • . Proportion of patients having a recurrence of the BV [ Time Frame: Up to day 42 ]
    Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
Official Title  ICMJE An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis
Brief Summary This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed BV according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE Device: pHyph, Gedea pessary
pHyph is a vaginal tablet for the treatment of BV.
Study Arms  ICMJE Experimental: pHyph, Gedea Pessary
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.
Intervention: Device: pHyph, Gedea pessary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 18, 2019
Actual Primary Completion Date October 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Adult, post-menarchal, pre-menopausal women aged 18 years or older

  • Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 following criteria:

    1. Thin, white, yellow, homogenous discharge
    2. Clue cells on microscopy (more than 20 percent of epithelial cells)
    3. pH of vaginal fluid above 4.5
    4. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
  • Having decisional capacity and providing written informed consent
  • Negative urine pregnancy test at screening
  • Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
  • Refrain from sexual intercourse or use a condom until Day 7
  • Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria:

Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening

  • Anticipated menstruation during the treatment period (Day 0 till Day 7)
  • Patients who are pregnant or breastfeeding
  • Patients who were treated for BV within the past 14 days
  • Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
  • Patients who have used pH-modifying vaginal products within the last 14 days
  • Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
  • Known/previous allergy or hypersensitivity to any product constituent
  • Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03762083
Other Study ID Numbers  ICMJE QRS-CL2-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gedea Biotech AB
Study Sponsor  ICMJE Gedea Biotech AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Monika Cardell, MD, PhD Kvinnokliniken, Region Skåne
PRS Account Gedea Biotech AB
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP