CCT-102 for Miscarriage

(MERMAID Trial)

Recruiting at27 trial locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Conceptra Biosciences, LLC

Must not be taking: Anticoagulants, Corticosteroids, Prostaglandins, others

Disqualifiers: Ectopic pregnancy, Anemia, IUD, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called CCT-102 to help women who have early pregnancies that stopped developing. The treatment aims to help clear the non-developing pregnancy tissue from their uterus. The study compares this treatment to simply waiting and monitoring the condition.

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.

Research Team

Eligibility Criteria

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

If a fetus is present, the gestational period has been observed to be no more than 10 weeks.

My heart and blood circulation are stable.

A gestational sac with a diameter of 25 mm or more is present, but no embryo can be detected.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants choose between the CCT-102 regimen or expectant management for uterine evacuation

7 days

1 visit (in-person) on Day 1, evaluation on Day 7

Follow-up

Participants are monitored for resolution of DPL and safety until Day 28

21 days

Follow-up visits as needed

Treatment Details

Interventions

• CCT-102 (Other)

Trial Overview The study compares CCT-102 A and CCT-102 B treatments against waiting for natural resolution in cases of delayed pregnancy loss. It aims to see if these treatments can help clear the uterus more effectively than expectant management.

Participant Groups

Group I: CCT-102 Regimen Active Control 1 Intervention

CCT-102 A/B regimen

Group II: Expectant management Active Control 1 Intervention

Non-treatment, 'waitful watching'

Who Is Running the Clinical Trial?

Conceptra Biosciences, LLC

Lead Sponsor

Trials

2

Recruited

340+