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Dopamine Agonist

Cabergoline for Inhibition of Lactation (eLISTA Trial)

Phase 2

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant people, ages 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 4 after procedure

Awards & highlights

eLISTA Trial Summary

This trial will study the use of cabergoline to reduce breast pain & distress after 2nd trimester abortion or loss. It may also provide insight into reducing symptoms earlier in the pregnancy.

Who is the study for?

This trial is for pregnant individuals aged 18 or older who are undergoing an early second-trimester abortion or managing a fetal demise at 16-20 weeks gestation. Participants must have access to a smartphone, be able to understand English or Spanish, and willing to follow study procedures. Those with uncontrolled high blood pressure, prior mastectomy, current breastfeeding, dopamine therapy use, heart valve disorders, or fibrotic disorders cannot join.Check my eligibility

What is being tested?

The trial is testing if Cabergoline can prevent breast pain and milk production after an early second-trimester loss compared to a placebo. It builds on previous findings that the drug helps later in pregnancy by seeing if it's effective earlier on.See study design

What are the potential side effects?

Cabergoline may cause side effects like nausea, headache, dizziness and possibly affect blood pressure. Since it's being used here for lactation inhibition after pregnancy loss rather than its usual uses (like treating Parkinson's), participants will be monitored closely.

eLISTA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant and 18 years or older.

eLISTA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 4 after procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 4 after procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4 after procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Reporting Breast Pain

Secondary outcome measures

Number of Participants Experiencing Side-effects

Number of Participants Reporting Significant Bother From Breast Pain

Number of Participants Reporting Significant Bother From Side-effects

eLISTA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CabergolineExperimental Treatment1 Intervention

After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.

Group II: PlaceboPlacebo Group1 Intervention

After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabergoline 1 MG

2021

Completed Phase 2

~80

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,390 Previous Clinical Trials

17,340,655 Total Patients Enrolled

Planned Parenthood Mar MonteUNKNOWN

1 Previous Clinical Trials

1,770 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food & Drug Administration certified Cabergoline?

"Cabergoline is a relatively safe medication, so it receives an estimation of 2 on our 1-3 scale. This rating was decided as the trial is in Phase 2, meaning there are preliminary safety results but no evidence that this drug works effectively for its intended use."

Answered by AI

Is the recruitment for this research still open?

"As stated on clinicaltrials.gov, patient recruitment for this trial has ceased as of the most recent update dated September 1st 2023. Despite its closure to new participants, there are still other trials recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss

2024. "Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029673.