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Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis (Nefertiti)

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: NCT04640922
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Gedea Biotech AB

Brief Summary:

This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV.

The study population will consist of post-menarchal, pre-menopausal females 18 years or older seeking for BV symptoms (fishy smell, irritation and burning).

Patients will be recruited at study sites' gynaecological and sexual health clinics and a total of 150 patients are planned to be randomised in the study.

On Day 0, patients will have gynaecological examination, vaginal samples taken, and will be randomised in a 4:1 relation to receive treatment with 6 doses of the Gedea Pessary or a vehicle control (placebo) to be self-administered daily (Days 0 to 5). Patients will be re examined at Day 7 (+2 days) for clinical cure rate.

Patients that are clinically cured at Day 7 will continue to the second part of the study and will be randomised in a 1:1 relation to either Gedea Pessary or placebo treatment, to be self administered once a week for a duration of 126 days.

Patients not clinically cured at Day 7 will be offered rescue treatment (metronidazole) for 7 days. They will return at Day 14 for clinical assessment and sampling for microbiome and mycobiome analysis, and if cured they will be assessed for recurrence up to Day 128. Patients that are not cured at Day 14 will be discontinued from the study.

Patients that are clinically cured at Day 7 and continuing in Part 2 will be followed up until confirmed recurrence or Day 128 if no recurrence. Vaginal samples will be taken by self-swab on Days 35, 63 and 91, a visit to the clinic will be performed at Day 63 and telephone follow up will be done at Days 35 and 91. Vaginal samples will also be taken at the visit on the Day of potential recurrence and/or at Day 128 if no recurrence.

Vaginal samples will be used for confirming the diagnosis (Nugent score on Day 0 and Day 7) and sequencing analysis of the vaginal microbiome and mycobiome (Days 0, 7, 35, 63, 91 and Day of confirmed recurrence or Day 128 if no recurrence).

Patient follow-up as regards to patient questionnaire/usability, AEs and BV recurrence notification will be handled with a mobile phone application. In case of a suspected BV recurrence, the patient should return to the clinic for confirmation of BV diagnosis.


Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Device: Gedea Pessary pHyph Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double-blind placebo-controlled multi-centre study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis
Actual Study Start Date : January 27, 2020
Actual Primary Completion Date : January 31, 2022
Actual Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Active Comparator: Gedea Pessary
pHyph, vaginal tablet, daily in Part 1 and once weekly in Part 2
Device: Gedea Pessary pHyph
Vaginal tablet

Placebo Comparator: Placebo
placebo, vaginal tablet, daily in Part 1 and once weekly in Part 2
Device: Placebo
Vaginal tablet




Primary Outcome Measures :
  1. Clinical cure rate on Day 7 [ Time Frame: Day 7 ]

    o 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 odour "i.e. a positive whiff test" when alkali (10% KOH solution) is added.


Secondary Outcome Measures :
  1. Safety and local tolerability of Gedea Pessary - based on reported treatment-emergent AEs up until Day 7. [ Time Frame: Day 7 ]
    Part 1

  2. Clinical cure rate on Day 7, defined as clinical cure according to primary endpoint and Nugent score <4, i.e. both criteria have to be fulfilled. [ Time Frame: Day 7 ]
    Part 1

  3. Difference between Day 7 and Days 35, 63, 91, 128 and/or Day of possible recurrence confirmation (assessed by Amsel criteria), respectively, in the occurrence of anaerobic vaginal dysbiosis as assessed by analysis of the vaginal microbiome. [ Time Frame: Day 35, 63, 91, and 128, respectively ]
    Part 2



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Adult, post-menarchal, pre-menopausal women aged 18 years or older.
  2. Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 criteria.
  3. Having decisional capacity and providing written informed consent.
  4. Negative urine pregnancy test at screening.
  5. Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants or tampons, etc.) until Day 7 and the following 24 hours after each treatment during weekly treatment.
  6. Refrain from sexual intercourse or use a condom until Day 7.
  7. Willing to use contraception (if heterosexual) for 128 days.
  8. Signed informed consent and willing and able to comply with all study requirements.

Exclusion Criteria:

  1. Patients with known or apparent signs of other infectious causes of vaginitis (e.g.

    vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening.

  2. Anticipated menstruation during the treatment period (Day 0 till Day 5).
  3. Patients who are pregnant or breastfeeding.
  4. Patients who are planning to conceive within the 128 days study duration.
  5. Patients who were treated for BV within the past 14 days.
  6. Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days.
  7. Patients who have used pH-modifying vaginal products within the last 14 days.
  8. Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening.
  9. Known/previous allergy or hypersensitivity to any product constituent.
  10. 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): NCT04640922


Locations
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Sweden
Hoftekliniken
Helsingborg, Sweden
Curakliniken
Malmö, Sweden
United Kingdom
Derbyshire Community Health Services NHS Foundation Trust
Derby, United Kingdom
Northamptonshire Healthcare NHS Foundation Trust (NHFT)
Northampton, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Sponsors and Collaborators
Gedea Biotech AB
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Responsible Party: Gedea Biotech AB
ClinicalTrials.gov Identifier: NCT04640922    
Other Study ID Numbers: QRS-CL3-003
CIV-GB-20-09-034813 ( Other Identifier: EUDAMED )
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis