Cabergoline for Inhibition of Lactation

(eLISTA Trial)

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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.

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.

What evidence supports the effectiveness of the drug cabergoline for inhibiting lactation?

Research shows that cabergoline is effective in stopping milk production after childbirth. In studies, a single dose of cabergoline successfully prevented lactation in most women, with higher doses being more effective. It is also well-tolerated compared to other treatments like bromocriptine. ^{1 2 3 4 5}

Is cabergoline safe for humans?

Cabergoline is generally considered safe for humans, with most side effects being mild and short-lived, such as dizziness, headache, and nausea. However, rare but serious events have been reported, so monitoring is advised. ^{1 2 5 6 7}

How does the drug cabergoline differ from other treatments for lactation inhibition?

Cabergoline is unique because it is a long-acting dopamine agonist that can effectively inhibit lactation with a single oral dose, unlike bromocriptine, which requires multiple doses over 14 days. This makes cabergoline more convenient and potentially better tolerated for women who need to stop lactation. ^{1 2 5 8 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral cabergoline. Single-dose inhibition of puerperal lactation. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Cabergoline: a new drug for the treatment of hyperprolactinaemia. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of cabergoline for lactation inhibition in women living with HIV. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Prevention of puerperal lactation by a single oral administration of the new prolactin-inhibiting drug, cabergoline. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Cabergoline for suppression of puerperal lactation in a prevention of mother-to-child HIV-transmission programme in rural Malawi. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Cabergoline. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of Cabergoline for Postpartum Lactation Inhibition or Suppression: A Systematic Review. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Is Cabergoline Safe and Effective for Postpartum Lactation Inhibition? A Systematic Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Single dose cabergoline versus bromocriptine in inhibition of puerperal lactation: randomised, double blind, multicentre study. European Multicentre Study Group for Cabergoline in Lactation Inhibition. [2019]