Last updated: January 5, 2024
Sponsor: Jeremy Burton
Overall Status: Active - Not Recruiting
Phase
3
Condition
Vaginal Infection
Bacterial Infections
Vaginal Atrophy
Treatment
Preforpro
Placebo
Clinical Study ID
NCT05590195
BVPFB2021
Ages 18-45 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female
- 18-45 years old premenopausal (period within 6 months)
- Nugent score of 4-6 (intermediate) or 7-10 (BV)
- Have an ability to collect a clean urine sample
- Prescription and over the counter medication unchanged for > 30 days prior to thestudy. -Participants who are taking medications as needed (PRN) may be included ifthey began PRN usage >30 days prior to baseline
- Sexually active status of the participants can be either active or inactive
- Participants must agree to use a medically approved method of birth control (e.g.hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barriermethods and double-barrier method) and must have negative pregnancy test results atscreening and baseline
Exclusion
Exclusion Criteria:
- Faecal incontinence
- History of urinary fistula, bladder or kidney stones, interstitial cystitis, orcystoscopic abnormalities that could be malignant
- Neurogenic bladder
- A history of currently undergoing immunosuppressive drug therapy, chemotherapy, orradiation therapy
- Antibiotic and/or anti-fungal medication used within the last four weeks
- Oral probiotic supplement use within 2 weeks prior the study excluding yogurt
- Drug abuse
- Uncontrolled psychological disorders
Study Design
Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Preforpro
Phase: 3
Study Start date:
May 01, 2024
Estimated Completion Date:
June 01, 2025