CCT-102 or Expectant Management in Delayed Pregnancy Loss

Completed · Phase 3

Conditions studied: Early Pregnancy Loss, Delayed Pregnancy Loss

In brief

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).

Key facts

Study ID

NCT06121063

Run by

Conceptra Biosciences, LLC

People needed

183

Starts

2023-07-21

Expected to finish

2025-07-30

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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