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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

Must not have

Currently receiving dopamine agonist or antagonist therapy for other indication leg syndrome)

Contraindication to cabergoline (as per package insert)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 4 after procedure

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am pregnant and 18 years or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for restless leg syndrome.

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I cannot take cabergoline due to health reasons.

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I have had heart valve problems or surgery.

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I have a history of fibrosis in my lungs, heart sac, or behind my abdomen.

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My blood pressure is higher than 160/110, I take multiple medications for it, or I have pregnancy-related high blood pressure.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Reporting Breast Pain

Secondary study objectives

Number of Participants Experiencing Side-effects

Number of Participants Reporting Significant Bother From Breast Pain

Number of Participants Reporting Significant Bother From Side-effects

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 / 6Eligibility criteria met