Cabergoline for Inhibition of Lactation

(eLISTA Trial)

No longer recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Dopamine agonists, Dopamine antagonists

Disqualifiers: Mastectomy, Breastfeeding, Hypertension, Cardiac disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cabergoline, a medication, can prevent breast pain and milk leakage after a second-trimester abortion or fetal loss between 16 and 20 weeks. Previous studies have shown its effectiveness in later stages, and researchers now seek to assess its efficacy earlier. Participants will receive either cabergoline or a placebo to compare outcomes. Suitable candidates include English or Spanish-speaking pregnant individuals who have experienced an abortion or are managing a fetal loss between 16 and 20 weeks of pregnancy. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant early-stage findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving dopamine agonist or antagonist therapy for other conditions. If you have uncontrolled hypertension requiring more than one medication, you may also be excluded.

Is there any evidence suggesting that cabergoline is likely to be safe for humans?

Studies have shown that cabergoline is generally well tolerated for stopping breast milk production. Some people report mild side effects, such as dizziness, headache, nausea, and vomiting. These side effects are usually not severe and are mostly manageable, often not lasting long.

It's important to note that while cabergoline is safely used in many cases, it should not be used to stop breast milk production immediately after childbirth due to the risk of serious side effects. In this study, researchers are exploring cabergoline for a different purpose, and past research suggests it has a promising safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lactation inhibition, which often involve hormonal therapies like estrogen or bromocriptine, cabergoline works differently by directly targeting dopamine receptors to reduce prolactin levels. Researchers are excited about cabergoline because it can be taken as a single oral dose, offering a convenient and potentially faster-acting option compared to treatments that require multiple doses over time. This specificity in action and ease of administration could lead to fewer side effects and improved patient compliance, making it a promising alternative for those needing lactation suppression.

What evidence suggests that cabergoline might be an effective treatment for lactation inhibition?

Research has shown that cabergoline, which participants in this trial may receive, effectively stops milk production. In past cases, 78% to 100% of patients using cabergoline successfully prevented milk production. One study found that cabergoline also helped prevent breast pain and swelling after a second-trimester abortion or loss. Compared to other treatments like bromocriptine, cabergoline works just as well but with fewer side effects. This suggests that cabergoline could help reduce breast pain and milk leakage after an early second-trimester abortion. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to comply with study procedures and follow-up

Intrauterine pregnancy between 16/0-19/6 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit)

Consented for an induced, elective abortion or undergoing management of fetal demise

Exclusion Criteria

I have had a mastectomy or surgery to reduce breast size or masculinize my chest.

I am currently taking medication for restless leg syndrome.

I cannot take cabergoline due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either cabergoline 1 mg or placebo orally on the day of the procedure

1 day

1 visit (in-person)

Follow-up

Participants complete surveys to assess symptoms and side-effects at baseline and on Day 2, 4, 7, and 14 after the procedure

2 weeks

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cabergoline

Trial Overview 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.

How Is the Trial Designed?

Group I: Cabergoline Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Cabergoline is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Dostinex for:

• Hyperprolactinemia
• Parkinsonian Syndrome

Approved in United States as Dostinex for:

• Hyperprolactinemia
• Parkinsonian Syndrome

Approved in Canada as Dostinex for:

• Hyperprolactinemia
• Parkinsonian Syndrome

Approved in Japan as Dostinex for:

• Hyperprolactinemia
• Parkinsonian Syndrome

Approved in Switzerland as Dostinex for:

• Hyperprolactinemia
• Parkinsonian Syndrome

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Planned Parenthood Mar Monte

Collaborator

Trials

2

Recruited

1,800+

Published Research Related to This Trial

Cabergoline (CAB) is a highly effective treatment for hyperprolactinaemia, showing greater potency and longer-lasting effects compared to bromocriptine, with significant tumor shrinkage observed in patients with macroprolactinoma.

CAB is well-tolerated by most patients and is recommended as the first-line treatment for hyperprolactinaemic disorders, although women planning to conceive should discontinue use one month prior to trying to become pregnant due to limited data on its effects during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabergoline. Colao, A., Lombardi, G., Annunziato, L.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7069562/

Is Cabergoline Safe and Effective for Postpartum Lactation ... Cabergoline is non-inferior to bromocriptine for lactation inhibition while also associated with fewer rebound symptoms and adverse effects.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31183987/

Cabergoline: a review of its use in the inhibition of lactation ... Cabergoline is at least as effective as bromocriptine for lactation inhibition with success rates between 78% and 100%. Transient, mild to moderate adverse ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000293782300738X

The efficiency of cabergoline vs pyridoxine for lactation ... Cabergoline was superior to pyridoxine in inhibiting lactation. Cabergoline had more adverse effects, but no major adverse effect was documented in both ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06909123

A Reduced Dose of Cabergoline for Lactation Inhibition ... Recently, our own research found a single dose of cabergoline 1 mg effectively prevents breast symptoms after a second-trimester abortion or ...

5. labeling.pfizer.com labeling.pfizer.com/ShowLabeling.aspx?id=13930

Dostinex Tablets (Cabergoline) In controlled clinical trials, DOSTINEX given as a single 1 mg administration during the first day post-partum, was effective in inhibiting milk secretion, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK501327/

Cabergoline - Drugs and Lactation Database (LactMed®) - NCBI Cabergoline was generally well tolerated for use in suppressing lactation, but dizziness, headache, nausea and vomiting occur occasionally.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/020664s016lbl.pdf

DOSTINEX (cabergoline) tablets, for oral use Avoid use of DOSTINEX for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions. Use of ...

8. lacted.org lacted.org/questions/cabergoline-safety-for-lactation-suppression/

Cabergoline Safety for Lactation Suppression This systematic review demonstrates that adverse events were generally benign and tolerable following the administration of cabergoline.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31285168/

Safety of Cabergoline for Postpartum Lactation Inhibition or ... In conclusion, this systematic review demonstrates that adverse events were generally benign and tolerable following the administration of cabergoline. However, ...