Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

• ClinicalTrials.gov Identifier: NCT03762083
• Recruitment Status: Completed
• First Posted: December 3, 2018
• Last Update Posted: November 22, 2019
• Sponsor: Gedea Biotech AB
• Information provided by (Responsible Party): Gedea Biotech AB

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• 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
• Actual Study Completion Date: November 18, 2019

Arms and Interventions

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.

Outcome Measures

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?"

Eligibility Criteria

• 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

Contacts and Locations

Locations

Sweden

Stortorgets Gynekologmottagning

Helsingborg, Sweden

Sophiakliniken

Lund, Sweden

Sponsors and Collaborators

Gedea Biotech AB

Investigators

• Principal Investigator: Monika Cardell, MD, PhD; Kvinnokliniken, Region Skåne

More Information

Additional Information:

Sponsor webpage 

• Responsible Party: Gedea Biotech AB
• ClinicalTrials.gov Identifier: NCT03762083
• Other Study ID Numbers: QRS-CL2-003
• First Posted: December 3, 2018
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

• 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:

Vaginosis, Bacterial; Vaginal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infections; Vaginitis