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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 : Active, not recruiting
First Posted : December 3, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Gedea Biotech AB

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).

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Device: pHyph, Gedea pessary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : October 22, 2019
Estimated Study Completion Date : November 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: pHyph, Gedea Pessary
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.
Device: pHyph, Gedea pessary
pHyph is a vaginal tablet for the treatment of BV.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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]

  3. 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?"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762083


Locations
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Sweden
Stortorgets Gynekologmottagning
Helsingborg, Sweden
Sophiakliniken
Lund, Sweden
Sponsors and Collaborators
Gedea Biotech AB
Investigators
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Principal Investigator: Monika Cardell, MD, PhD Kvinnokliniken, Region Skåne

Additional Information:
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Responsible Party: Gedea Biotech AB
ClinicalTrials.gov Identifier: NCT03762083     History of Changes
Other Study ID Numbers: QRS-CL2-003
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gedea Biotech AB:
vaginitis
vaginal disease
vulvovaginitis
genital disease, female
vaginitis, bacterial
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis