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NCT07453069 · ClinicalTrials.gov registry record · Phase 2
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
A Phase 2 study, sponsored by Freya Biosciences ApS.
- Not yet
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT07453069 is a Phase 2 study that has not yet begun recruiting, run by Freya Biosciences ApS. The registered enrollment target is 30 participants.
The verdict
NCT07453069, a Phase 2 study, has not yet begun recruiting, sponsored by Freya Biosciences ApS.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 40 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis). The main question it aims to answer is: • Does treatment with FB301 during a mock FET cycle change the proportion of participants who meet the predefined vaginal bacterial threshold compared with placebo? Researchers will compare: * FB301 given after an initial vaginal cleansing with chlorhexidine (an antiseptic solution), * FB301 given after an initial vaginal cleansing with saline (saltwater), and * A placebo capsule given after an initial vaginal cleansing with saline to determine whether these approaches affect vaginal bacterial composition and pregnancy outcomes. Participants will take study treatment for 15 days during a "mock" FET cycle. In a mock cycle, participants receive the hormones needed to prepare the uterus for embryo transfer, but no embryo is transferred. After completing the mock cycle, participants will proceed with their planned frozen embryo transfer and will be followed during pregnancy until birth. Participants will: * Undergo a vaginal cleansing before receiving the first dose of FB301 or placebo * Provide vaginal swab samples at up to 5 study visits * Attend the study centre for up to 8 visits and participate in up to 4 follow-up phone calls * Complete a mock FET cycle before proceeding with their planned frozen embryo transfer cycle Participants who become pregnant will be followed until birth.
Interventions
- DRUG Placebo
- DRUG FB-301
- OTHER Chlorhexidine (0.5%) Vaginal Cleanse
- OTHER Sham vaginal cleanse (saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-04-15 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07453069
The ClinicalTrials.gov registry entry for NCT07453069 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Freya Biosciences ApS, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT07453069 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07453069 about?
NCT07453069 is a clinical study titled "Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle". The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 40 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis). The main question it aims to answer is: • Does treatment with FB301 durin...
What is the current status of trial NCT07453069?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-04-15. Estimated completion is 2027-09-30.
What interventions are being tested in trial NCT07453069?
The interventions under investigation include: Placebo (DRUG), FB-301 (DRUG), Chlorhexidine (0.5%) Vaginal Cleanse (OTHER), Sham vaginal cleanse (saline) (OTHER).
Who is sponsoring clinical trial NCT07453069?
This trial is sponsored by Freya Biosciences ApS, which has 2 total clinical trials registered on ClinicalTrials.gov.
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