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Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms

NCT07492160 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2026-03-25

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether cabergoline can prevent lactation and reduce breast symptoms in pregnant people aged 18 years or older undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation. The main questions it aims to answer are:

Does cabergoline decrease the proportion of participants who experience breast symptoms (including breast engorgement, milk leakage, tenderness, and need for pain relief) after abortion or pregnancy loss?

Does cabergoline reduce the severity of breast symptoms and associated bother compared with placebo?

Researchers will compare participants receiving cabergoline to those receiving placebo to determine whether cabergoline reduces the frequency and severity of breast symptoms following abortion or pregnancy loss.

Participants will:

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

Receive a single oral dose of either cabergoline (1 mg) or placebo approximately one hour after the procedure

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

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

Conditions

  • Pregnancy
  • Abortion

Interventions

DRUG

Cabergoline

Participants will receive a single oral dose of 1 mg of Cabergoline administered approximately one hour after completion of the abortion or pregnancy loss procedure. Cabergoline is a dopamine agonist that suppresses prolactin secretion and is used in this study to inhibit lactation and reduce breast symptoms.

DRUG

Placebo

Participants will receive a single oral dose of a placebo tablet administered approximately one hour after completion of the abortion or pregnancy loss procedure. The placebo will be identical in appearance to the cabergoline tablet and contains no active medication

Sponsors & Collaborators

  • Maimonides Medical Center

    lead OTHER

Principal Investigators

  • June Ng, MD · Maimonides Medical Canter

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2028-02-29
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492160 on ClinicalTrials.gov