FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL (NCT07281404)
Open-label Lead-in Study of Single-dose 0.7% YASO GEL Followed by a Phase 1 Randomized, Double-blind Dose-escalation Study to Assess Safety and Pharmacokinetics of 2% YASO GEL
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to assess the safety and pharmacokinetics of YASO GEL in healthy adult participants. This is a first-in-human study designed to understand how the gel is absorbed and distributed in plasma and vaginal fluid, and to evaluate the methods used to measure drug levels in humans. The main questions the study aims to answer are: What is the preliminary safety and tolerability of YASO GEL at a subtherapeutic 0.7% dose? How is YASO GEL absorbed and distributed, and does sexual activity affect its pharmacokinetics? Participants will: Receive an application of YASO GEL. Provide blood and vaginal fluid samples for pharmacokinetic analysis. Participate in a sub-study evaluating the impact of sexual activity on safety and drug exposure. Additional information on product acceptability, adherence, and exploratory laboratory analyses will be collected to inform the design of future studies.
Who can join: Review the eligibility criteria below.
Location: UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania
📞 Contact the Study Coordinator
Phone: 974-6694-9579
Email: pquy@yasotherapeutics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Early-phase Safety and PK Study of a Vaginal Gel clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.