Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:46 AM
Study NCT ID:
NCT07492160
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077465', 'term': 'Cabergoline'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-02-27', 'size': 131692, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-16T15:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Double-blinded (Participant, Care Provider)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 348}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Breast Symptoms 4 Days After Abortion or Pregnancy Loss', 'timeFrame': '4 days after abortion or pregnancy loss', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Participant-Reported Bother/Satisfaction From Breast Symptoms & Serum Prolactin Levels', 'timeFrame': 'Days 0, 2, 3, 4, 7, and 14 after abortion or pregnancy loss', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cabergoline', 'pregnancy'], 'conditions': ['Pregnancy', 'Abortion']}, 'referencesModule': {'references': [{'pmid': '37486652', 'type': 'BACKGROUND', 'citation': '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': '41538804', 'type': 'BACKGROUND', 'citation': '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': '1676318', 'type': 'BACKGROUND', 'citation': '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': '32210637', 'type': 'BACKGROUND', 'citation': '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': '31285168', 'type': 'BACKGROUND', 'citation': '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': '2037265', 'type': 'BACKGROUND', 'citation': "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': '8672187', 'type': 'BACKGROUND', 'citation': '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': '25761676', 'type': 'BACKGROUND', 'citation': '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': '2220345', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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?\n\nDoes cabergoline reduce the severity of breast symptoms and associated bother compared with placebo?\n\nResearchers 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.\n\nParticipants will:\n\nComplete a baseline survey assessing breast symptoms prior to the abortion or pregnancy loss procedure\n\nReceive a single oral dose of either cabergoline (1 mg) or placebo approximately one hour after the procedure\n\nComplete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess breast symptoms and related bother\n\nA subset of participants will provide blood samples at selected time points to measure serum prolactin levels', 'detailedDescription': '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.\n\nHistorically, 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.\n\nThis 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.\n\nThe 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.\n\nIn 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.\n\nParticipants 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.\n\nA 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.\n\nBy 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant people aged 18 years or older\n* Gestational age between 12 and 18 weeks\n* Undergoing treatment for spontaneous or induced abortion at Maimonides Medical Center\n* Able to provide informed consent\n* Willing and able to complete study surveys\n\nExclusion Criteria:\n\n* Prior mastectomy\n* Currently breastfeeding\n* Current use of a dopamine agonist or dopamine antagonist medication\n* Known contraindication to Cabergoline according to the medication prescribing information'}, 'identificationModule': {'nctId': 'NCT07492160', 'briefTitle': 'Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Maimonides Medical Center'}, 'officialTitle': 'Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms After 12-18 Week Abortion or Pregnancy Loss: A Pilot and Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-07-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabergoline', 'description': '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.', 'interventionNames': ['Drug: Cabergoline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cabergoline', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cabergoline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'June Ng, MD', 'role': 'CONTACT', 'email': 'JuNg@maimo.org', 'phone': '718-283-7048'}, {'name': 'June Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'centralContacts': [{'name': 'June Ng, MD', 'role': 'CONTACT', 'email': 'JuNg@maimo.org', 'phone': '718-283-7048'}, {'name': 'Olivia Sher, MPH', 'role': 'CONTACT', 'email': 'OSher@maimo.org', 'phone': '718-283-7962'}], 'overallOfficials': [{'name': 'June Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maimonides Medical Canter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimonides Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'June Ng', 'investigatorAffiliation': 'Maimonides Medical Center'}}}}