CCT-102 for Miscarriage
(MERMAID Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CCT-102, a potential drug to assist with miscarriage in the first trimester. Researchers aim to determine if CCT-102 can safely clear the uterus compared to natural resolution. Eligible participants include women with a confirmed miscarriage by ultrasound who are not experiencing bleeding or an open cervix. The trial compares the CCT-102 treatment to monitoring the condition without intervention. As a Phase 3 trial, this study is the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anticoagulants or chronic corticosteroids. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that CCT-102 is likely to be safe for humans?
Research shows that CCT-102 has been tested in earlier studies and is generally well-tolerated by participants. Although detailed safety information for CCT-102 is not available, it is now in a Phase 3 trial, indicating it has already passed initial safety tests with smaller groups. These trials usually focus on the treatment's effectiveness and monitor any side effects in a larger group.
While specific side effects for CCT-102 aren't listed, advancing to this trial phase suggests no serious safety issues were found earlier. Participants are closely monitored during trials for any negative reactions. Those considering joining should consult the trial team or their doctor to learn more about possible risks.12345Why do researchers think this study treatment might be promising?
Unlike the standard care options for miscarriage, which often include approaches like medication (misoprostol) or surgical procedures (dilation and curettage), CCT-102 is unique because it offers a distinct regimen aimed at managing miscarriage. Researchers are excited about CCT-102 because it introduces a novel mechanism that could potentially improve outcomes by targeting underlying biological pathways differently than current methods. This new approach might provide a more effective and less invasive treatment option, offering hope for individuals seeking alternatives to conventional miscarriage management.
What evidence suggests that CCT-102 might be an effective treatment for miscarriage?
In this trial, participants will receive either the CCT-102 regimen or expectant management. Previous studies have shown that active management strategies like CCT-102 resolve early pregnancy loss more effectively than expectant management, which takes a wait-and-see approach. Research indicates that active management often leads to a more successful resolution of the condition, effectively clearing the uterus. Success rates for similar treatments are very high, with surgical methods being almost 99% effective. Although researchers are still studying CCT-102, early results are promising and suggest it may help women with non-progressing miscarriages.12367
Are You a Good Fit for This Trial?
This trial is for women aged 18 to 50 who have experienced a non-progressing miscarriage in the first trimester. Participants must be stable, able to consent, and have specific clinical signs of early pregnancy loss with no more than 10 weeks gestation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants choose between the CCT-102 regimen or expectant management for uterine evacuation
Follow-up
Participants are monitored for resolution of DPL and safety until Day 28
What Are the Treatments Tested in This Trial?
Interventions
- CCT-102
Find a Clinic Near You
Who Is Running the Clinical Trial?
Conceptra Biosciences, LLC
Lead Sponsor