NCT06121063

CCT-102 or Expectant Management in Delayed Pregnancy Loss

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Conceptra Biosciences, LLC · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Early Pregnancy Loss, Delayed Pregnancy Loss

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CCT-102 A and CCT-102 B	2 day oral regimen

Timeline

• Start date: 2023-07-21
• Primary completion: 2025-05-15
• Completion: 2025-07-30
• First posted: 2023-11-07
• Last updated: 2025-08-22

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study