Cabergoline for Lactation Inhibition After Abortion
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete a baseline survey assessing breast symptoms prior to the abortion or pregnancy loss procedure
Treatment
Participants receive a single oral dose of either cabergoline or placebo approximately one hour after the procedure
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
Optional Blood Sampling
A subset of participants provide blood samples at selected time points to measure serum prolactin levels
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
Participants undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation will receive a single 1 mg oral dose of Cabergoline approximately one hour after the procedure. Participants will complete baseline and follow-up surveys assessing breast symptoms, including breast engorgement, milk leakage, tenderness, and need for pain relief, at multiple time points through 14 days after the procedure. A subset of participants may also provide blood samples for measurement of serum prolactin levels.
Participants undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation will receive a single oral dose of placebo approximately one hour after the procedure. Participants will complete baseline and follow-up surveys assessing breast symptoms, including breast engorgement, milk leakage, tenderness, and need for pain relief, at multiple time points through 14 days after the procedure. A subset of participants may also provide blood samples for measurement of serum prolactin levels.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maimonides Medical Center
Lead Sponsor
Jefferson Drapkin
Lead Sponsor
Citations
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 ...
3.
journals.lww.com
journals.lww.com/ogopen/fulltext/2025/12000/a_prospective_cohort_study_of_cabergoline_for.7.aspxA 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.
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 ...
9.
stanfordhealthcare.org
stanfordhealthcare.org/stanford-health-care-now.html/presentation-mode/stanford-health-care-now/2023/clinical-trial-shows-cabergoline-prevents-breast-symptomsClinical 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.
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