Status:
COMPLETED
CCT-102 or Expectant Management in Delayed Pregnancy Loss
Lead Sponsor:
Conceptra Biosciences, LLC
Conditions:
Early Pregnancy Loss, Delayed Pregnancy Loss
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
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).
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 h...
Eligibility Criteria
Inclusion
- Age 18 to 50
- Ability to provide informed consent
- Hemodynamically stable
- Closed cervical os
- If fetus exists, clinical observation indicates gestation is no more than 10 weeks
- Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on:
- Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,
- Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, with no detectable embryo.
Exclusion
- Unwillingness or inability to comply with the study protocol and visit schedule
- Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week.
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- Hemoglobin \<10 g/dL
- Coagulation disorder, inherited porphyrias, and/or current anticoagulants use
- Chronic adrenal failure
- Concurrent chronic corticosteroid therapy
- History of trophoblastic disease
- Current presence of an IUD
- History of allergy or contraindications to the use to mifepristone, misoprostol, or other prostaglandins
- Any condition that, in the opinion of the investigator, makes the patient unsuitable for study entry
- Any other current medical condition that jeopardizes the patient's ability to safely participate in the trial
Key Trial Info
Start Date :
July 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT06121063
Start Date
July 21 2023
End Date
July 30 2025
Last Update
August 22 2025
Active Locations (15)
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1
Noble Clinical Research
Tucson, Arizona, United States, 85704
2
Amicis Research Center, LLC
San Fernando, California, United States, 91340
3
Emerald Coast Obstetrics and Gynecology
Panama City, Florida, United States, 32405
4
Cypress Medical Research Center
Wichita, Kansas, United States, 67226