Early Pregnancy Loss, Delayed Pregnancy LossPhase 3MERMAIDNCT06121063
CCT-102 or Expectant Management in Delayed Pregnancy Loss
A Phase 3 study testing CCT-102 A and CCT-102 B in people with Early Pregnancy Loss, Delayed Pregnancy Loss, run by Conceptra Biosciences, LLC at 15 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy Loss, Delayed Pregnancy Loss
- What is being tested?
- CCT-102 A and CCT-102 B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Jul 2023to 30 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Penn State Hershey Obstetrics and Gynecology
Hershey, Pennsylvania, 17033
Las Vegas Clinical Trials
Las Vegas, Nevada, 89030
Maximos Obstetrics & Gynecology
League City, Texas, 77573
Prime Clinical Research - Lewisville North Valley
Lewisville, Texas, 75067
Eastern Carolina Women's Center, PA
New Bern, North Carolina, 28562
Columbia University Irving Medical Center
New York, New York, 10032
Emerald Coast Obstetrics and Gynecology
Panama City, Florida, 32405
Amicis Research Center, LLC
San Fernando, California, 91340
Montefiore Medical Center
The Bronx, New York, 10461
Noble Clinical Research
Tucson, Arizona, 85704
Tidewater Clinical Research
Virginia Beach, Virginia, 23456
Cypress Medical Research Center
Wichita, Kansas, 67226
Lyndhurst Clin Research
Winston-Salem, North Carolina, 27103
About this study
Official title: 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).
Read the 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.
- Being tested
- CCT-102 A and CCT-102 B
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCT-102 A and CCT-102 BCombination product
2 day oral regimen
| Study group | Role | What they receive |
|---|---|---|
| CCT-102 Regimen | Active comparator | CCT-102 A/B regimen Receives: Combination Product: CCT-102 A and CCT-102 B |
| Expectant management | No intervention | Non-treatment, 'waitful watching' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of pregnancy loss
Evacuation of delayed pregnancy loss within 7 days (up to and including Day 7), confirmed by ultrasound.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start21 Jul 2023
- Primary completion15 May 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy Loss, Delayed Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open, label, multi-center, randomized study
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conceptra Biosciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121063
- Sponsor's protocol ID
- PRT-CO-CCT-102.001
- Acronym
- MERMAID
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a CCT-102 Regimen or Expectant Management in the Treatment of First Trimester Pregnancy Loss
- ClinicalTrials.gov ID
- NCT06121063
- Acronym / sponsor ID
- MERMAID / PRT-CO-CCT-102.001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Conceptra Biosciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open, label, multi-center, randomized study
| Arm | Type | Receives |
|---|---|---|
| CCT-102 Regimen | Active comparator | Combination Product: CCT-102 A and CCT-102 BCCT-102 A/B regimen |
| Expectant management | No intervention | –Non-treatment, 'waitful watching' |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCT-102 A and CCT-102 B2 day oral regimen | Combination product | CCT-102 Regimen |
Primary outcome
Resolution of pregnancy loss
Time frame: 7 Days
Evacuation of delayed pregnancy loss within 7 days (up to and including Day 7), confirmed by ultrasound.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CCT-102 A and CCT-102 B in people with Early Pregnancy Loss, Delayed Pregnancy Loss, run by Conceptra Biosciences, LLC at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of pregnancy loss (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.