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Study of YASO GEL for Contraception

This study is testing a new contraceptive gel called YASO GEL. It's an early-stage study to see how safe YASO GEL is and how your body handles it (pharmacokinetics). Researchers want to understand how the gel is absorbed into your blood and vaginal fluid. They will also look at whether sexual activity changes how the gel works. Both YASO GEL and an inactive placebo gel will be used. The study is looking for 72 healthy adults, aged 18 to 55, including women aged 18-45 and men 18 and over. Success means understanding the gel's safety and how it moves through the body.

Study design
This is an interventional study with 72 planned participants. It includes a lead-in phase and a randomized, double-blind Phase 1 study.
What's involved
You will receive an application of YASO GEL, provide blood and vaginal fluid samples, and may participate in a sub-study looking at the impact of sexual activity.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first dose through 3 days post-dose (Lead-in), 21 days post-dose (Phase 1, Stage 1), 28 days post first dose (Phase 1, Stage 2), and 24 hours post dose (coital sub-study).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07281404

FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL

Not Yet Recruiting
EARLY_PHASE1Ages 18–55InterventionalTreatment
Yaso Therapeutics Corporation
~72 participants
Updated 2025-12-19 on ClinicalTrials.gov
What's tested:YASO GELPlacebo gel

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events
Measured over Incidence of treatment-emergent adverse events, measured from first dose through Day 3 post-dose (Lead-in), 21 days post-dose (Phase 1, Stage 1), 28 days post first dose (Phase 1, stage 2) and 24 hours post dose (coital sub-study).
+1 more outcome measured

Conditions

Early-phase Safety and PK Study of a Vaginal Gel

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Healthy Volunteers

NCT07281404

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvaniano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Beatrice Chen, MD MPH · PRINCIPAL_INVESTIGATOR · UPMC Magee-Womens Hospital

Who to contact

Philippa Quy
[email protected]
974-6694-9579
Email the study team

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Eligibility criteria

Inclusion

4.1.1 Lead-in and Phase 1 Studies
Women aged 18 through 45 years (inclusive)
Men aged 18 years and over at Screening 2. Cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy 3. Able to communicate in English 4. Provide written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 5. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures. 6. Provide adequate locator information (per site SOP) 7. Understand and agree to local STI reporting requirements 8. In general good health, in the opinion of the investigator 9. Agree not to participate in other concurrent interventional and/or drug trials
hormonal methods (except contraceptive vaginal rings)
IUD
sterilization of participant or partner
heterosexual abstinence
sexually abstinent for the past 90 days before enrollment and planning to remain abstinent for the duration of study participation 4. Must agree to abstain from insertion of anything other than IP into the vagina or anus (e.g., penis, tongue, finger, sex toy, lubricant, tampon, etc.) for at least 48 hours prior to the Enrollment Visit, the duration of treatment, and at least 48 hours after treatment.
Use of any genitally applied products other than IP (except soap/water for general hygiene and study provided condoms for at least 24 hours prior to treatment days and at least 48-hr after treatment
Masturbation or intercourse (anal, vaginal, or receptive oral) on treatment days and at least 48-hr after treatment
hormonal methods (except contraceptive vaginal rings)
IUD
Female sterilization 5. Must agree to abstain from use of any vaginal products (e.g., lubricants, feminine hygiene products, sex toys, vaginally administered contraceptive products with the exception of study provided condoms) other than IP for at least 48 hours prior to coital visits and at least 48 hr after coital visits
use of any genitally applied products, except soap/water for general hygiene, for at least 24 hours prior to coital visits and at least 48-hr after coital visits
masturbation or intercourse (anal, vaginal, or receptive oral) for 72 hours before each coital visit. 2. Have no history of abnormal sperm or semen abnormality

Exclusion

4.2.1 Lead-in and Phase 1 Study, as well as the Sub-Study Individuals who meet any of the following criteria will be excluded from the study
(140 - age in yrs) x (weight in kg) x (0.85)/72 x (serum Cr in mg/dL)
(140 - age in yrs) x (weight in kg)/72 x (serum Cr in mg/dL) 15. Symptomatic and/or clinical or laboratory diagnosis of urinary tract infection (UTI) or reproductive tract infection requiring treatment per current CDC guidelines at screening (may rescreen after treatment). 16. Any condition that, in the opinion of the Principal Investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives

What this trial measures

  • Incidence of treatment-emergent adverse eventsIncidence of treatment-emergent adverse events, measured from first dose through Day 3 post-dose (Lead-in), 21 days post-dose (Phase 1, Stage 1), 28 days post first dose (Phase 1, stage 2) and 24 hours post dose (coital sub-study).

    Number, type, and severity of adverse events observed from first dose through end of follow-up per study section.

  • Plasma and vaginal fluid concentrations of investigational contraceptiveTime from first dose to last PK sample collection per study section: lead-in up to Day 3; Phase 1 Stage 1 up to Day 21; Phase 1 Stage 2 up to Day 28; sub-study up to 24 hours post dose; samples collected at multiple predefined timepoints.

    Concentrations of the investigational contraceptive measured in blood plasma and vaginal fluid at predefined timepoints from first dose through last PK sample per study section.