Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms

NCT07492160 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2025-07-24
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cabergoline; pregnancy

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Breast Symptoms 4 Days After Abortion or Pregnancy Loss

  The proportion of participants reporting any breast symptoms, including breast engorgement, milk leakage, tenderness, or need for pain relief, assessed using the Bristol Breast Symptoms Inventory.

  4 days after abortion or pregnancy loss

Secondary Outcomes (1)

• Participant-Reported Bother/Satisfaction From Breast Symptoms & Serum Prolactin Levels

  Days 0, 2, 3, 4, 7, and 14 after abortion or pregnancy loss

Study Arms (2)

Cabergoline

EXPERIMENTAL

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.

Drug: Cabergoline

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Cabergoline DRUG

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.

Cabergoline

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant people aged 18 years or older
• Gestational age between 12 and 18 weeks
• Undergoing treatment for spontaneous or induced abortion at Maimonides Medical Center
• Able to provide informed consent
• Willing and able to complete study surveys

You may not qualify if:

• Prior mastectomy
• Currently breastfeeding
• Current use of a dopamine agonist or dopamine antagonist medication
• Known contraindication to Cabergoline according to the medication prescribing information

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

Related Publications (9)

• Henkel A, Johnson SA, Reeves MF, Cahill EP, Blumenthal PD, Shaw KA. Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jun 1;141(6):1115-1123. doi: 10.1097/AOG.0000000000005190. Epub 2023 May 3.

  PMID: 37486652 BACKGROUND

• Henkel A, Cahill EP, Chavez S, Shorter JM, Amaya SI, Kaur S, Soltani A, Caron J, Crowe S, Williams Z, Mastey N, Lyell DJ, Shaw KA. Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial. Obstet Gynecol. 2026 Feb 1;147(2):277-284. doi: 10.1097/AOG.0000000000006137. Epub 2025 Dec 5.

  PMID: 41538804 BACKGROUND

• Single dose cabergoline versus bromocriptine in inhibition of puerperal lactation: randomised, double blind, multicentre study. European Multicentre Study Group for Cabergoline in Lactation Inhibition. BMJ. 1991 Jun 8;302(6789):1367-71. doi: 10.1136/bmj.302.6789.1367.

  PMID: 1676318 BACKGROUND

• Yang Y, Boucoiran I, Tulloch KJ, Poliquin V. Is Cabergoline Safe and Effective for Postpartum Lactation Inhibition? A Systematic Review. Int J Womens Health. 2020 Mar 9;12:159-170. doi: 10.2147/IJWH.S232693. eCollection 2020.

  PMID: 32210637 BACKGROUND

• Harris K, Murphy KE, Horn D, MacGilivray J, Yudin MH. Safety of Cabergoline for Postpartum Lactation Inhibition or Suppression: A Systematic Review. J Obstet Gynaecol Can. 2020 Mar;42(3):308-315.e20. doi: 10.1016/j.jogc.2019.03.014. Epub 2019 Jul 6.

  PMID: 31285168 BACKGROUND

• Giorda G, de Vincentiis S, Motta T, Casazza S, Fadin M, D'Alberton A. Cabergoline versus bromocriptine in suppression of lactation after cesarean delivery. Gynecol Obstet Invest. 1991;31(2):93-6. doi: 10.1159/000293109.

  PMID: 2037265 BACKGROUND

• Rayburn WF. Clinical commentary: the bromocriptine (Parlodel) controversy and recommendations for lactation suppression. Am J Perinatol. 1996 Feb;13(2):69-71. doi: 10.1055/s-2007-994294.

  PMID: 8672187 BACKGROUND

• Bernard N, Jantzem H, Becker M, Pecriaux C, Benard-Laribiere A, Montastruc JL, Descotes J, Vial T; French Network of Regional Pharmacovigilance Centres. Severe adverse effects of bromocriptine in lactation inhibition: a pharmacovigilance survey. BJOG. 2015 Aug;122(9):1244-51. doi: 10.1111/1471-0528.13352. Epub 2015 Mar 11.

  PMID: 25761676 BACKGROUND

• Nyboe Andersen A, Damm P, Tabor A, Pedersen IM, Harring M. Prevention of breast pain and milk secretion with bromocriptine after second-trimester abortion. Acta Obstet Gynecol Scand. 1990;69(3):235-8. doi: 10.3109/00016349009028686.

  PMID: 2220345 BACKGROUND

MeSH Terms

Interventions

Cabergoline

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• June Ng, MD

  Maimonides Medical Canter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

June Ng, MD

CONTACT

718-283-7048; JuNg@maimo.org

Olivia Sher, MPH

CONTACT

718-283-7962; OSher@maimo.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Double-blinded (Participant, Care Provider)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)