348 Participants NeededMy employer runs this trial

Cabergoline for Lactation Inhibition After Abortion

JN
OS
Overseen ByOlivia Sher, MPH
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cabergoline can prevent breast symptoms such as engorgement, milk leakage, and tenderness after a pregnancy ends between 12 and 18 weeks. Researchers seek to discover if cabergoline reduces these symptoms and the associated discomfort compared to a placebo. Participants will receive either cabergoline or a placebo and will report their symptoms over two weeks. This trial suits those who were pregnant for 12 to 18 weeks, are not currently breastfeeding, and can visit Maimonides Medical Center for treatment. As a Phase 2 trial, this research measures cabergoline's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

If you are currently taking a dopamine agonist or dopamine antagonist medication, you will need to stop, as these are part of the exclusion criteria for the trial.

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

Research has shown that cabergoline is generally safe and well-tolerated for stopping milk production. In previous studies, common side effects included dizziness, headache, nausea, and vomiting, but these occurred infrequently. One study found that side effects were mild and similar for both cabergoline and placebo groups, suggesting the treatment rarely causes serious problems. For instance, in a review of 757 women, only 14.2% experienced side effects, with dizziness and headache being the most common.

The FDA has already approved cabergoline for stopping milk production after childbirth, which supports its safety. However, understanding possible side effects and discussing them with a healthcare provider before joining a trial is important.12345

Why do researchers think this study treatment might be promising?

Cabergoline is unique because it directly targets prolactin, the hormone responsible for lactation, and reduces its levels. This is different from standard treatments like bromocriptine, which also targets prolactin but has a more complex side effect profile. Researchers are excited about cabergoline because it offers a single-dose oral administration, which is more convenient and potentially more tolerable for patients. Additionally, cabergoline's targeted action provides a rapid onset of relief from symptoms like breast engorgement and tenderness, potentially improving patient comfort significantly after an abortion or pregnancy loss.

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

Studies have shown that cabergoline effectively prevents breast symptoms after a second-trimester abortion or pregnancy loss. In this trial, participants will receive either a single dose of cabergoline or a placebo. Research indicates that a single dose of cabergoline can reduce the likelihood of breast tenderness, swelling, and milk leakage. For example, one study found that individuals who took cabergoline experienced fewer symptoms compared to those who did not. Cabergoline lowers prolactin, a hormone responsible for milk production, which helps prevent these uncomfortable breast symptoms. Overall, cabergoline has proven to be a well-tolerated and effective option for managing these issues.678910

Who Is on the Research Team?

JN

June Ng, MD

Principal Investigator

Maimonides Medical Canter

Are You a Good Fit for This Trial?

This trial is for pregnant people aged 18 or older who are having an abortion or pregnancy loss between 12 and 18 weeks at Maimonides Medical Center. Participants must not be breastfeeding, taking certain medications, have had a mastectomy, or have conditions that make cabergoline unsafe.

Inclusion Criteria

Undergoing treatment for spontaneous or induced abortion at Maimonides Medical Center
Gestational age between 12 and 18 weeks
Able to provide informed consent
See 2 more

Exclusion Criteria

I am currently taking a medication that affects dopamine.
Currently breastfeeding
I do not have any known reasons that prevent me from taking Cabergoline.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Assessment

Participants complete a baseline survey assessing breast symptoms prior to the abortion or pregnancy loss procedure

1 day
1 visit (in-person)

Treatment

Participants receive a single oral dose of either cabergoline or placebo approximately one hour after the procedure

1 day
1 visit (in-person)

Follow-up

Participants complete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess breast symptoms and related bother

2 weeks
5 visits (virtual)

Optional Blood Sampling

A subset of participants provide blood samples at selected time points to measure serum prolactin levels

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cabergoline

Trial Overview

The study compares a single dose of cabergoline versus placebo given after abortion or pregnancy loss to see if it prevents lactation and reduces breast symptoms like pain, swelling, and milk leakage. Participants complete surveys about their symptoms over two weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: CabergolineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Maimonides Medical Center

Lead Sponsor

Trials
72
Recruited
15,400+

Jefferson Drapkin

Lead Sponsor

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41538804/

Cabergoline for Lactation Inhibition After Early Second- ...

Conclusion: Cabergoline is an effective and well-tolerated medication to prevent breast symptoms after early second-trimester abortion or ...

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 ...

A Prospective Cohort Study of Cabergoline for Inhibition of ...

Cabergoline intake was associated with lower incidence of breast symptoms. Our results are limited by the small number who declined cabergoline.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37486652/

Cabergoline for Lactation Inhibition After Second-Trimester ...

Cabergoline is an effective and well-tolerated strategy to prevent breast symptoms after second-trimester abortion or pregnancy loss.

TITLE Efficacy of Cabergoline in Inhibiting Lactation and ...

For example, Hagey et al found that 50% of patients undergoing abortion or pregnancy loss between 14 and 20 weeks experience breast tenderness, ...

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.

Is Cabergoline Safe and Effective for Postpartum Lactation ...

Cabergoline is simple, effective and generally safe when given to postpartum women either wishing or needing to suppress lactation.

Dostinex Tablets (Cabergoline)

DOSTINEX is indicated for the inhibition of physiological lactation soon after delivery and for suppression of already established lactation: 1. After ...

Clinical Trial Shows Cabergoline Prevents Breast ...

Importantly, side effects were rare but similar between the cabergoline and placebo groups. Fewer people reported hot flashes or significant ...

Safety of Cabergoline for Postpartum Lactation Inhibition or ...

This systematic review demonstrates that adverse events were generally benign and tolerable following the administration of cabergoline.