CCT-102 or Expectant Management in Delayed Pregnancy Loss (MERMAID)

The Efficacy and Safety of a CCT-102 Regimen or Expectant Management in the Treatment of First Trimester Pregnancy Loss

A Phase 3, multi-center clinical trial of a CCT-102 regimen or expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL).

Study Overview

• Status: Completed
• Conditions: Early Pregnancy Loss, Delayed Pregnancy Loss
• Intervention / Treatment: Combination product: CCT-102 A and CCT-102 B

Detailed Description

This is a Phase 3, open-label, multi-center study to assess the efficacy of a CCT-102 regimen for uterine evacuation in first trimester delayed pregnancy loss (DPL). Eligible study participants will have ultrasound documented DPL with estimated gestational age 10 weeks or less.

DPL is defined as arrest of embryonic or fetal development, in first trimester, where the cervix is closed and there is no or only slight bleeding. This includes: 1) anembryonic pregnancy, and 2) embryonic demise. Expectant management, which is an accepted treatment protocol recognized in 2018 ACOG Practice Bulletin on Early Pregnancy Loss (ACOG, 2018), consists of patient monitoring with no additional treatment.

Eligible participants will choose between the investigational product or expectant management on Day 1. They will be evaluated for the primary endpoint (resolution of DPL) on Study Day 7. All participants will be followed to Day 28.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
  • California
    • San Fernando, California, United States, 91340
      • Amicis Research Center, LLC
  • Florida
    • Panama City, Florida, United States, 32405
      • Emerald Coast Obstetrics and Gynecology
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • Nevada
    • Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center, PA
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clin Research
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Obstetrics and Gynecology
  • Texas
    • Galveston, Texas, United States, 77555
      • The University of Texas Medical Branch at Galveston
    • League City, Texas, United States, 77573
      • Maximos Obstetrics & Gynecology
    • Lewisville, Texas, United States, 75067
      • Prime Clinical Research - Lewisville North Valley
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • Tidewater Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18 to 50
2. Ability to provide informed consent
3. Hemodynamically stable
4. Closed cervical os
5. If fetus exists, clinical observation indicates gestation is no more than 10 weeks

6. Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on:

   1. Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,
   2. Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, with no detectable embryo.

Exclusion Criteria:

1. Unwillingness or inability to comply with the study protocol and visit schedule
2. Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week.
3. Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
4. Hemoglobin <10 g/dL
5. Coagulation disorder, inherited porphyrias, and/or current anticoagulants use
6. Chronic adrenal failure
7. Concurrent chronic corticosteroid therapy
8. History of trophoblastic disease
9. Current presence of an IUD
10. History of allergy or contraindications to the use to mifepristone, misoprostol, or other prostaglandins
11. Any condition that, in the opinion of the investigator, makes the patient unsuitable for study entry
12. Any other current medical condition that jeopardizes the patient's ability to safely participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CCT-102 Regimen; CCT-102 A/B regimen	Combination product: CCT-102 A and CCT-102 B; 2 day oral regimen
No Intervention: Expectant management; Non-treatment, 'waitful watching'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of pregnancy loss	Evacuation of delayed pregnancy loss within 7 days (up to and including Day 7), confirmed by ultrasound.	7 Days

Collaborators and Investigators

• Sponsor: Conceptra Biosciences, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Abortion, Spontaneous; Fetal Death
• Other Study ID Numbers: PRT-CO-CCT-102.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No