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PregnancyPhase 2NCT07492160

Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms

A Phase 2 study testing Cabergoline in people with Pregnancy and Abortion, run by Jefferson Drapkin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Abortion
What is being tested?
Cabergoline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
348 participants
Where
1 siteUnited States
Study dates
16 Mar 2026to Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

June Ng, MD contact

718-283-7048

JuNg@maimo.org

Olivia Sher, MPH contact

718-283-7962

OSher@maimo.org

United States1 site, 1 recruiting
  • Maimonides Medical Center

    Brooklyn, New York, 11219

    June Ng, MD, 718-283-7048, JuNg@maimo.org

    June Ng, MD

    Recruiting

Other trials in United States

About this study

Official title: Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms After 12-18 Week Abortion or Pregnancy Loss: A Pilot and Randomized Controlled Trial

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?

Read more

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

Read the detailed description

Breast symptoms such as breast engorgement, milk leakage, and tenderness are common after abortion or pregnancy loss in the second trimester because lactation can begin as early as 12-20 weeks of gestation. While care following abortion or pregnancy loss often focuses on pelvic symptoms, breast symptoms may also cause significant physical discomfort and emotional distress for patients. Prior research suggests that a large proportion of patients undergoing abortion or pregnancy loss between 14 and 20 weeks experience breast tenderness, engorgement, or milk production. However, the frequency and severity of these symptoms earlier in the second trimester (12-18 weeks) has not been well characterized.

Historically, medications such as bromocriptine were used to suppress lactation following pregnancy termination or delivery. However, bromocriptine has been associated with serious cardiovascular, neurologic, and psychiatric side effects and is no longer recommended for lactation suppression in the United States. Cabergoline, a dopamine agonist that suppresses prolactin secretion, has emerged as a safer alternative and has been shown to be effective in suppressing lactation after full-term delivery. More recent studies suggest that cabergoline may also reduce breast symptoms following abortion or pregnancy loss in the later second trimester, but limited evidence exists for individuals between 12 and 18 weeks of gestation.

This study aims to evaluate both the prevalence of breast symptoms and the effectiveness of cabergoline for preventing these symptoms among individuals undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation.

The study will include two phases conducted at Maimonides Medical Center. In the first phase, participants will complete a survey assessing baseline breast symptoms prior to the abortion or pregnancy loss procedure. The survey will use the Bristol Breast Symptoms Inventory, a validated instrument that measures the severity of breast engorgement, milk leakage, tenderness, and the need for pain relief. This phase will allow researchers to estimate how frequently breast symptoms occur in this population.

In the second phase, participants will be enrolled in a double-blind randomized controlled trial. Participants will be randomly assigned to receive either a single oral dose of cabergoline (1 mg) or a placebo approximately one hour after the abortion or pregnancy loss procedure. Both participants and clinical providers will be blinded to the treatment assignment.

Participants will complete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess the presence and severity of breast symptoms as well as the level of bother caused by these symptoms. The primary outcome of the study will be the proportion of participants reporting breast symptoms four days after the procedure. Secondary outcomes include the severity of individual breast symptoms, overall symptom bother, and participant satisfaction.

A subset of approximately 20 participants will also be invited to provide blood samples at several time points during the study to measure serum prolactin levels. These measurements will help evaluate the biological effect of cabergoline on lactation-related hormone levels. Participation in blood sampling will be optional and not required for participation in the main study.

By evaluating both the frequency of breast symptoms and the effectiveness of cabergoline for preventing them, this study aims to improve clinical care and patient comfort for individuals undergoing abortion or pregnancy loss in the early second trimester.

Conditions
Pregnancy, Abortion
Being tested
Cabergoline, Placebo
Keywords
cabergoline, pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabergolineDrug

    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.

  • PlaceboDrug

    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

Study groups in NCT07492160
Study groupRoleWhat they receive
CabergolineExperimentalParticipants 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.
Receives: Drug: Cabergoline
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 days after abortion or pregnancy loss

Secondary outcomes (1)
  1. Participant-Reported Bother/Satisfaction From Breast Symptoms & Serum Prolactin Levels

    Participant-reported level of bother related to breast symptoms following abortion or pregnancy loss, assessed using survey responses. Participant satisfaction with breast symptom management following abortion or pregnancy loss, assessed through survey responses. Serum prolactin levels measured in a subset of participants to evaluate the physiologic effect of cabergoline on lactation-related hormone levels.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start16 Mar 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
348 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07492160
Sponsor's protocol ID
2025-07-24
Status last verified
Sep 2026
First submitted
19 Mar 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy concerns and the potential risk of participant identification given the sensitive nature of the study population and clinical context. Only aggregate study results will be reported.

Publications

  • 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.

    PubMed 37486652
  • 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.

    PubMed 41538804
  • 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.

    PubMed 1676318
  • 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.

    PubMed 32210637
  • 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.

    PubMed 31285168
  • 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.

    PubMed 2037265
  • 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.

    PubMed 8672187
  • 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.

    PubMed 25761676
  • 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.

    PubMed 2220345

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabergoline in people with Pregnancy and Abortion, run by Jefferson Drapkin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact June Ng, MD (718-283-7048, JuNg@maimo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Breast Symptoms 4 Days After Abortion or Pregnancy Loss (time frame: 4 days after abortion or pregnancy loss). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07492160, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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