Early-phase Safety and PK Study of a Vaginal GelEarly Phase 1PPCM-01NCT07281404
FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL
A Early Phase 1 study testing YASO GEL in people with Early-phase Safety and PK Study of a Vaginal Gel, run by Yaso Therapeutics Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Early-phase Safety and PK Study of a Vaginal Gel
- What is being tested?
- YASO GEL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 4.1.1 Lead-in and Phase 1 Studies
- Individuals who meet the following criteria are eligible for inclusion in the study (see additional gender specific criteria at the end of the section):
- Adults who are:
- Women aged 18 through 45 years (inclusive)
- Men aged 18 years and over at Screening
- Cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy
Show all 55Show fewer
- Able to communicate in English
- 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.
- Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
- Provide adequate locator information (per site SOP)
- Understand and agree to local STI reporting requirements
- In general good health, in the opinion of the investigator
- Agree not to participate in other concurrent interventional and/or drug trials
- Female specific criteria:
- Women ≥ 21 years must have documentation of a satisfactory Pap within the past 3 years consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result. If result is not available, Pap test will be performed at screening.
- Regular menstrual cycles of approximately 21 to 35 days apart with no undiagnosed intermenstrual menstrual bleeding Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills, patches, or progestin-only contraceptive methods (progestin-only pills, depot medroxyprogesterone acetate (DMPA), etonogestrel subdermal implant, or levonorgestrel-releasing IUD), as the absence of regular menstrual cycles and break-through bleeding are common in these contexts.
- Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Acceptable methods are:
- 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
- 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.
- Male specific criteria:
- Must agree to abstain from:
- 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
- 4.1.2 Inclusion Criteria - Sub-Study
- Heterosexual couples who meet the following criteria are eligible for inclusion in the study:
- Couple-level criteria:
- Women aged 18 through 45 years (inclusive) and men aged 18 through 55 years (inclusive) at screening
- 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.
- Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
- Heterosexual couples in a mutually monogamous relationship ≥ 6 months prior to Screening with intent to remain in relationship for duration of study participation
- Both partners willing to participate and coitally active
- Cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy
- Both partners independently report not using barrier contraception and/or barrier protection as part of normal coital routine and report the intent to continue said sexual practice for the duration of study participation
- Able to communicate in English
- Provide adequate locator information, as defined in site SOP
- Must be in general good health in the opinion of the investigator
- Must agree to not to participate in other concurrent interventional and/or drug trials
- Female specific inclusion criteria:
- Not pregnant or breastfeeding and not planning pregnancy during study participation
- Women ≥ 21 years must have documentation of a satisfactory Pap within the past 3 years consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result. If result is not available, Pap test will be performed at Screening.
- Regular menstrual cycles of approximately 21 to 35 days apart with no undiagnosed intermenstrual menstrual bleeding Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills, patches, or progestin-only contraceptive methods (progestin-only pills, depot medroxyprogesterone acetate (DMPA), etonogestrel subdermal implant, or levonorgestrel-releasing IUD), as the absence of regular menstrual cycles and break-through bleeding are common in these contexts.
- Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Acceptable methods are:
- hormonal methods (except contraceptive vaginal rings)
- IUD
- Female sterilization
- 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
- Male specific inclusion criteria:
- Must agree to abstain from
- 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.
- Have no history of abnormal sperm or semen abnormality
Who cannot join
- 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
- General exclusions:
- Plans to relocate away from the study site area during the period of study participation
- Genital piercings and/or tattoos
- Have been diagnosed with genital HSV, with the first occurrence (initial episode) within three months prior to Screening
- Have had three or more outbreaks of genital HSV within the last year
Show all 42Show fewer
- History of recurrent rash/dermatosis (e.g., eczema) in the genital area
- History of autoimmune disease
- History of adverse reaction to PPCM, methylparaben, propylparaben, hydroxypropyl methylcellulose (HPMC), or xanthan gum
- Known HIV seropositivity
- Non-therapeutic injection drug use in the 6 months prior to Screening
- Use of HIV PrEP or post-exposure prophylaxis within prior 6 months
- Use of systemic immunomodulatory medications within the 30 days prior to planned enrollment
- Participation in another research study involving drugs or medical devices within the 30 days prior to Enrollment
- Recent use (within last 14 days) and/or unwillingness to abstain from use of vaginally administered medications (including condoms containing Nonoxynol-9 [N-9]) for the duration of the study from enrollment through all follow up visits but not including periods between study phases.
- Laboratory abnormalities at screening:
- Note: Grade is per Version 2.1 of the DAIDS Toxicity Table
- HIV seropositive
- Decreased white blood cell count Grade 2 or higher
- Hemoglobin Grade 1 or higher
- Grade 2 or higher ALT and/or AST (i.e., ≥ 2.5x the site laboratory upper limit of normal [ULN])
- Calculated creatinine clearance Grade 2 or higher (i.e., ≤ 90 mL/minute using the Cockcroft-Gault equation.
- (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)
- 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).
- 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
- Female specific exclusion criteria:
- Currently pregnant as confirmed by urine HCG test at Screening and Enrollment
- Currently breastfeeding
- Intends to become pregnant during the period of study participation
- Pregnancy outcome 90 days or less prior to Screening
- Current or planned use of an intravaginal ring
- Gynecologic or urogenital procedure (e.g., cystoscopy, tubal ligation, dilation and curettage) within 45 days prior to Enrollment (exceptions: IUD insertion/removal, vaginal ultrasound, EMB, biopsy, Pap, colposcopy).
- Clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) at Screening or Enrollment.
- Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary.
- Note: Otherwise, eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved within 60 days of providing informed consent for screening.
- Male specific exclusion criteria:
- Diagnosis of phimosis, hypospadias, epispadias, or other abnormality that may impact safety or study evaluations
- History of treatment for candidal balanoposthitis/balanitis, epididymitis, or other genital lesion (warts, molluscum, etc.) within 30 days prior to Screening
- Urogenital procedure (e.g., cystoscopy, circumcision, vasectomy) within 45 days prior to enrollment
- Abnormal semen analysis (sub-study only).
- Vasectomy (sub-study only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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
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:
Read more
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.
Read the detailed description
This study initiates with a first-in-human lead-in study using a subtherapeutic 0.7% dose of YASO GEL. The study aims to provide a preliminary assessment of PPCM pharmacokinetics in plasma and vaginal fluid, and to validate a bioanalytical assay to be used to measure efficacy in both the Phase 1 and sub studies. Data from this study will help ensure that pharmacokinetic sampling is adequate for subsequent clinical trials and will provide initial safety information to support a Phase 1 study.
The subsequent randomized double-blind Phase 1 study will use a therapeutic 2.0% dose of YASO GEL administered once in Stage 1 of the Phase 1 study and once daily for 7 days in Stage 2 of the Phase 1 study. The Phase 1 study is designed to provide comprehensive baseline safety and pharmacokinetic data in a dose response manner. As such, it is important to assess the genitalia (vulva, perineum and vagina for female participants and penis, scrotum, and perineum for male participants) after each dose for safety, initially with single dose and then with repeated dosing. Because it is anticipated that a coitally-dependent product will be applied prior to each act of coitus, and individuals may have coitus more than once a day, future studies will evaluate more frequent dosing and further characterize the YASO GEL safety profile.
Secondarily, acceptability and adherence data will be collected to inform future product design and patient education. Exploratory endpoints include assessment of vaginal fluid samples for vaginal microbiome, soluble immune mediators, ex-vivo contraceptive activity and anti-microbial activity against both HIV and Ng.
A sub-study is included to evaluate the impact of coitus on safety and pharmacokinetics of YASO GEL use. This study will also collect acceptability and adherence data to inform future product design and patient education. Vaginal fluid samples will be assessed for contraceptive activity and ex vivo anti-microbial activity against both HIV and Ng, in an exploratory fashion to inform future study design.
The study will include healthy adult participants. Female participants will apply the gel internally in all studies. Male participants will apply the gel externally in the Lead-in and Phase 1 studies and be exposed to the gel in the coital sub-study. The results from this study will guide the design of future studies and help establish the safety and efficacy profile of YASO GEL in humans.
- Being tested
- YASO GEL, Placebo gel
- Keywords
- Contraceptive activity, HIV prevention, Antimicrobial activity, Sexual activity, Vaginal gel, YASO GEL, Coital exposure, First-in-human, Mucosal drug delivery
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YASO GELDrug
Contraceptive gel
Placebo gelDrug
Inactive placebo gel matching the investigational contraceptive
| Study group | Role | What they receive |
|---|---|---|
| Lead-in study | Experimental | Participants receive a single low dose of the investigational contraceptive to assess initial safety and tolerability. Receives: Drug: YASO GEL |
| Phase 1, Stage 1 - Active Drug | Experimental | Participants receive a single full-strength dose of the investigational contraceptive in a randomized, double-blind design. Receives: Drug: YASO GEL |
| Phase 1, Stage 1 - Placebo | Placebo comparator | Participants receive a single dose of placebo in a randomized, double-blind design. Receives: Drug: Placebo gel |
| Phase 1, Stage 2 - Active Drug | Experimental | Participants receive daily full-strength doses of the investigational contraceptive for 7 days in a randomized, double-blind design. Receives: Drug: YASO GEL |
| Phase 1, Stage 2 - Placebo | Placebo comparator | Participants receive daily placebo doses for 7 days in a randomized, double-blind design. Receives: Drug: Placebo gel |
| Coital Sub-study | Experimental | Participants receive full-strength investigational contraceptive in an open-label sub-study to further assess safety and exploratory endpoints. Receives: Drug: YASO GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Number, type, and severity of adverse events observed from first dose through end of follow-up per study section.
Measured: 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).
Plasma and vaginal fluid concentrations of investigational contraceptive
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.
Measured: Time 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.
Secondary outcomes (2)
Acceptability Questionnaire
To assess acceptability of IP use
Measured: Questionnaires administered at Day 2 post-dose during Phase 1, Stage 1 and on the final day of dosing, Day 7 during Phase 1, Stage 2 and immediately after intercourse on Day 3 of the coital sub-study.
Adherence to dosing schedule
Adherence to 7-day dosing schedule based on self-reported use evidenced by participant diaries, device logs, or returned product counts
Measured: Adherence based on self-reported use evidenced by participant diaries, device logs, or returned product counts post dosing on Day 1 and through Day 7 of the Phase 1, Stage 2 study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startApr 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-phase Safety and PK Study of a Vaginal GelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This first-in-human study consists of three parts. A 6-participant open-label lead-in cohort will receive a single low dose of the investigational contraceptive to assess initial safety and tolerability. The main Phase 1 study is a randomized, double-blind, parallel-group trial enrolling 32 participants, conducted in two stages: Stage 1 participants receive a single full-strength dose with 21-day follow-up, and Stage 2 participants receive daily full-strength doses for 7 days with 28-day follow-up. A 12-participant non-randomized coital sub-study will further assess safety and exploratory endpoints in the context of sexual activity, with and without use of the investigational product. Participants in the randomized Phase 1 portion remain in their assigned intervention arm throughout the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaso Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Magee-Women's Research Institute
- Responsible party
- Sponsor
- Investigators
- Beatrice Chen, MD MPH, Principal investigator, UPMC Magee-Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281404
- Sponsor's protocol ID
- PPCM-01
- Other IDs
- 1R44HD118927-01
- Acronym
- PPCM-01
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: External laboratories will perform assays as part of the study; no plans to share individual participant data outside the study team at this time.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07281404
- Acronym / sponsor ID
- PPCM-01 / PPCM-01
- Keywords
- Contraceptive activity, HIV prevention, Antimicrobial activity, Sexual activity, Vaginal gel, YASO GEL, Coital exposure, First-in-human
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Yaso Therapeutics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Magee-Women's Research Institute
- Study start
- Apr 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study initiates with a first-in-human lead-in study using a subtherapeutic 0.7% dose of YASO GEL. The study aims to provide a preliminary assessment of PPCM pharmacokinetics in plasma and vaginal fluid, and to validate a bioanalytical assay to be used to measure efficacy in both the Phase 1 and sub studies. Data from this study will help ensure that pharmacokinetic sampling is adequate for subsequent clinical trials and will provide initial safety information to support a Phase 1 study.
The subsequent randomized double-blind Phase 1 study will use a therapeutic 2.0% dose of YASO GEL administered once in Stage 1 of the Phase 1 study and once daily for 7 days in Stage 2 of the Phase 1 study. The Phase 1 study is designed to provide comprehensive baseline safety and pharmacokinetic data in a dose response manner. As such, it is important to assess the genitalia (vulva, perineum and vagina for female participants and penis, scrotum, and perineum for male participants) after each dose for safety, initially with single dose and then with repeated dosing. Because it is anticipated that a coitally-dependent product will be applied prior to each act of coitus, and individuals may have coitus more than once a day, future studies will evaluate more frequent dosing and further characterize the YASO GEL safety profile.
Secondarily, acceptability and adherence data will be collected to inform future product design and patient education. Exploratory endpoints include assessment of vaginal fluid samples for vaginal microbiome, soluble immune mediators, ex-vivo contraceptive activity and anti-microbial activity against both HIV and Ng.
A sub-study is included to evaluate the impact of coitus on safety and pharmacokinetics of YASO GEL use. This study will also collect acceptability and adherence data to inform future product design and patient education. Vaginal fluid samples will be assessed for contraceptive activity and ex vivo anti-microbial activity against both HIV and Ng, in an exploratory fashion to inform future study design.
The study will include healthy adult participants. Female participants will apply the gel internally in all studies. Male participants will apply the gel externally in the Lead-in and Phase 1 studies and be exposed to the gel in the coital sub-study. The results from this study will guide the design of future studies and help establish the safety and efficacy profile of YASO GEL in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This first-in-human study consists of three parts. A 6-participant open-label lead-in cohort will receive a single low dose of the investigational contraceptive to assess initial safety and tolerability. The main Phase 1 study is a randomized, double-blind, parallel-group trial enrolling 32 participants, conducted in two stages: Stage 1 participants receive a single full-strength dose with 21-day follow-up, and Stage 2 participants receive daily full-strength doses for 7 days with 28-day follow-up. A 12-participant non-randomized coital sub-study will further assess safety and exploratory endpoints in the context of sexual activity, with and without use of the investigational product. Participants in the randomized Phase 1 portion remain in their assigned intervention arm throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Lead-in study | Experimental | Drug: YASO GELParticipants receive a single low dose of the investigational contraceptive to assess initial safety and tolerability. |
| Phase 1, Stage 1 - Active Drug | Experimental | Drug: YASO GELParticipants receive a single full-strength dose of the investigational contraceptive in a randomized, double-blind design. |
| Phase 1, Stage 1 - Placebo | Placebo comparator | Drug: Placebo gelParticipants receive a single dose of placebo in a randomized, double-blind design. |
| Phase 1, Stage 2 - Active Drug | Experimental | Drug: YASO GELParticipants receive daily full-strength doses of the investigational contraceptive for 7 days in a randomized, double-blind design. |
| Phase 1, Stage 2 - Placebo | Placebo comparator | Drug: Placebo gelParticipants receive daily placebo doses for 7 days in a randomized, double-blind design. |
| Coital Sub-study | Experimental | Drug: YASO GELParticipants receive full-strength investigational contraceptive in an open-label sub-study to further assess safety and exploratory endpoints. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (55 listed)
- 4.1.1 Lead-in and Phase 1 Studies
- Individuals who meet the following criteria are eligible for inclusion in the study (see additional gender specific criteria at the end of the section):
- Adults who are:
- Cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy
- Able to communicate in English
Key exclusion criteria (42 listed)
- 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
- Plans to relocate away from the study site area during the period of study participation
- Genital piercings and/or tattoos
- Have been diagnosed with genital HSV, with the first occurrence (initial episode) within three months prior to Screening
- Have had three or more outbreaks of genital HSV within the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YASO GELContraceptive gel | Drug | Coital Sub-study, Lead-in study, Phase 1, Stage 1 - Active Drug, Phase 1, Stage 2 - Active Drug |
| Placebo gelInactive placebo gel matching the investigational contraceptive | Drug | Phase 1, Stage 1 - Placebo, Phase 1, Stage 2 - Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 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).
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 contraceptive
Time frame: Time 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.
2 secondary outcomes
Acceptability Questionnaire
Time frame: Questionnaires administered at Day 2 post-dose during Phase 1, Stage 1 and on the final day of dosing, Day 7 during Phase 1, Stage 2 and immediately after intercourse on Day 3 of the coital sub-study.
Adherence to dosing schedule
Time frame: Adherence based on self-reported use evidenced by participant diaries, device logs, or returned product counts post dosing on Day 1 and through Day 7 of the Phase 1, Stage 2 study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. External laboratories will perform assays as part of the study; no plans to share individual participant data outside the study team at this time.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrice Chen, MD MPH principal investigator
UPMC Magee-Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing YASO GEL in people with Early-phase Safety and PK Study of a Vaginal Gel, run by Yaso Therapeutics Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 55 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippa Quy (974-6694-9579, pquy@yasotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.