YASO GEL for Clinical Trials
(PPCM-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates a new gel, YASO GEL, to assess its safety and behavior in the body. Researchers aim to understand how the gel moves through the blood and vaginal fluid and whether sexual activity alters its effects. Participants will apply the gel and provide samples for testing. The study seeks healthy adults who can adhere to the trial's schedule and are not currently involved in other drug trials. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new gel works in people.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use vaginally administered medications during the study, and you must not have used systemic immunomodulatory medications within 30 days before joining. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that YASO GEL is likely to be safe for humans?
Research shows that YASO GEL is just beginning human testing, so information about its safety remains limited. The main ingredient, polyphenylene carboxymethylene (PPCM), has shown promise in lab and animal studies, particularly against certain infections. However, since this marks the first human trial of YASO GEL, its tolerance and potential side effects remain unknown.
At this early stage, the focus is on understanding how the gel is absorbed and distributed throughout the body. This is crucial for assessing basic safety and the body's reaction to the treatment. Early trials like this one carefully monitor for adverse reactions, but specific safety results will not be available until the study concludes. Participants in this trial will help researchers gather insights, paving the way for more detailed studies in the future.12345Why do researchers think this study treatment might be promising?
YASO GEL is unique because it offers a new approach to contraception. Unlike traditional oral contraceptives or hormonal implants, YASO GEL is a topical gel, providing an alternative delivery method that may be more convenient and comfortable for some users. Researchers are excited about its potential to provide effective contraception without the need for daily pills or invasive procedures, which could enhance user compliance and satisfaction. Additionally, the investigational gel is being explored for its safety and tolerability, potentially offering fewer side effects compared to existing hormonal methods.
What evidence suggests that YASO GEL might be an effective treatment for contraception?
Research shows that YASO GEL, containing the active ingredient PPCM, has delivered promising results. In animal studies, it completely prevented infection in mice when tested against certain sexually transmitted infections. This suggests that PPCM facilitates the breakdown of bacteria, potentially aiding in infection prevention. Additionally, PPCM has demonstrated strong contraceptive effects by interfering with sperm functions, such as causing premature loss of a part needed for fertilization. While these results are promising, more studies are necessary to confirm these effects in humans. Participants in this trial will receive YASO GEL in various treatment arms to assess its safety and effectiveness.25678
Who Is on the Research Team?
Beatrice Chen, MD MPH
Principal Investigator
UPMC Magee-Womens Hospital
Are You a Good Fit for This Trial?
This trial is for healthy adults to test YASO GEL's safety and how it's absorbed in the body. Participants will apply the gel, give blood and vaginal fluid samples, and some may join a sub-study on sexual activity effects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lead-in Study
Participants receive a single low dose of the investigational contraceptive to assess initial safety and tolerability.
Phase 1, Stage 1
Participants receive a single full-strength dose of the investigational contraceptive in a randomized, double-blind design.
Phase 1, Stage 2
Participants receive daily full-strength doses of the investigational contraceptive for 7 days in a randomized, double-blind design.
Coital Sub-study
Participants receive full-strength investigational contraceptive in an open-label sub-study to further assess safety and exploratory endpoints.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- YASO GEL
Trial Overview
YASO GEL is being tested against a placebo to see its safety at low doses and understand its absorption/distribution. The study also looks into whether sexual activity changes how the drug works in the body.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Participants receive daily full-strength doses of the investigational contraceptive for 7 days in a randomized, double-blind design.
Participants receive a single full-strength dose of the investigational contraceptive in a randomized, double-blind design.
Participants receive a single low dose of the investigational contraceptive to assess initial safety and tolerability.
Participants receive full-strength investigational contraceptive in an open-label sub-study to further assess safety and exploratory endpoints.
Participants receive a single dose of placebo in a randomized, double-blind design.
Participants receive daily placebo doses for 7 days in a randomized, double-blind design.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yaso Therapeutics Corporation
Lead Sponsor
Magee-Women's Research Institute
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Polyphenylene carboxymethylene (PPCM), the active ... - PMC
We next tested the in vivo efficacy of Yaso-GEL. The results showed Yaso-GEL to be highly effective compared with the placebo gel in ...
FIH Lead-in Study of YASO GEL Followed by a Phase 1 ...
The goal of this clinical trial is to assess the safety and pharmacokinetics of YASO GEL in healthy adult participants.
Abstract - Sexually Transmitted Infections
Yaso-GEL containing 4% PPCM prevented infection in 100% of mice. Incubation of N. gonorrhoeae with PPCM increased membrane permeability, suggesting PPCM ...
Evaluation of the novel vaginal contraceptive agent PPCM ...
As a contraceptive, PPCM has demonstrated significant contraceptive activity by causing premature acrosome loss (PAL), inactivating acrosomal enzymes ( ...
update on polyphenylene carboxymethylene MPT gel ...
Highly effective LARC's and contraceptive pills are available and widely used. Small changes to existing methods, primarily hormone-based methods and condoms, ...
Polyphenylene carboxymethylene (PPCM), the active ...
Yaso-GEL containing the API PPCM showed significant activity against N. gonorrhoeae in vitro and in vivo in a female mouse model.
Polyphenylene carboxymethylene (PPCM), the active ...
Yaso-GEL containing the API PPCM showed significant activity against N. gonorrhoeae in vitro and in vivo in a female mouse model.
FAQ
Preclinical data show Yaso Gel provides protection as soon as it is applied ... Yaso Gel with PPCM is much closer to real-world application in contraception.
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