Lactation SuppressedPhase 2eLISTANCT06029673
Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss
A Phase 2 study testing Cabergoline 1 MG in people with Lactation Suppressed, run by Stanford University at 2 sites in United States.
Trial summary
Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lactation Suppressed
- What is being tested?
- Cabergoline 1 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2024to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, ages 18 years or older
- Intrauterine pregnancy between 16/0-19/6 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit)
- Consented for an induced, elective abortion or undergoing management of fetal demise
- English or Spanish speaking
- Able to consent for a research study, literate in English or Spanish
- Willing to comply with study procedures and follow-up
Show all 14Show fewer
- Access to smart phone throughout study
- Pregnant people, ages 18 years or older
- Intrauterine pregnancy between 18/0-28/0 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit)
- Consented for an induced, elective abortion or undergoing induction for demise
- English or Spanish speaking
- Able to consent for a research study, literate in English or Spanish
- Willing to comply with study procedures and follow-up
- Access to smart phone throughout study
Who cannot join
- 18 Years Female No No
- Prior mastectomy (breast reduction or chest masculinization surgery acceptable)
- Currently breastfeeding
- Currently receiving dopamine agonist or antagonist therapy for other indication leg syndrome)
- Contraindication to cabergoline (as per package insert)
- Uncontrolled hypertension - defined as baseline BP > 160/110, or chronic hypertension requiring more than one baseline medication, or current pregnancy-induced hypertension spectrum disorders (gestational hypertension, preeclampsia, eclampsia)
- History of cardiac valvular disorders or valvular repair
- History of pulmonary, pericardial, or retroperitoneal fibrotic disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood - San Jose Central Health Center
San Jose, California, 95126
Stanford University
Stanford, California, 94305
About this study
Official title: Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial
Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.
Read the detailed description
This study is a double-blinded, placebo-controlled, gestational-age stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg or placebo the day of procedure. Participants will complete a survey to assess symptoms, using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day 2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to detect a 45% decrease in those reporting breast symptoms compared to the control group.
This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition in the early second-trimester after abortion or pregnancy loss.
- Conditions
- Lactation Suppressed
- Being tested
- Cabergoline 1 MG, Placebo
- Keywords
- abortion, fetal demise, lactation, engorgement
- Medical subject headings
- Fetal Death, Breast Feeding, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabergoline 1 MGDrug
Also called Dosintex
Dopamine agonist
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline | Experimental | After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator. Receives: Drug: Cabergoline 1 MG |
| Placebo | Placebo comparator | After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Breast Pain
Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.
Measured: Day 4 after procedure
Secondary outcomes (3)
Number of Participants Experiencing Side-effects
Participants selected from previously documented side-effects from the dopaminergic class or entered as free-text. Participants may have reported more than one side-effect. The experience of dopaminergetic medication side effects may or may not be considered to be adverse events.
Measured: Cumulative over 2 weeks
Number of Participants Reporting Significant Bother From Breast Pain
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother >=4
Measured: Day 4 after procedure
Number of Participants Reporting Significant Bother From Side-effects
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother >=4
Measured: Cumulative over 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start7 Feb 2024
- Primary completion15 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lactation SuppressedStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Mar Monte
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029673
- Sponsor's protocol ID
- 71540
- Acronym
- eLISTA
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2023
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be requested for meta-analysis inclusion
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06029673
- Acronym / sponsor ID
- eLISTA / 71540
- Conditions
- Lactation Suppressed
- Keywords
- abortion, fetal demise, lactation, engorgement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Planned Parenthood Mar Monte
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Posted 3 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.
Detailed description
This study is a double-blinded, placebo-controlled, gestational-age stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg or placebo the day of procedure. Participants will complete a survey to assess symptoms, using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day 2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to detect a 45% decrease in those reporting breast symptoms compared to the control group.
This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition in the early second-trimester after abortion or pregnancy loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabergoline | Experimental | Drug: Cabergoline 1 MGAfter the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator. |
| Placebo | Placebo comparator | Drug: PlaceboAfter the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pregnant people, ages 18 years or older
- Intrauterine pregnancy between 16/0-19/6 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit)
- Consented for an induced, elective abortion or undergoing management of fetal demise
- English or Spanish speaking
- Able to consent for a research study, literate in English or Spanish
Key exclusion criteria (8 listed)
- 18 Years Female No No
- Prior mastectomy (breast reduction or chest masculinization surgery acceptable)
- Currently breastfeeding
- Currently receiving dopamine agonist or antagonist therapy for other indication leg syndrome)
- Contraindication to cabergoline (as per package insert)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabergoline 1 MGAlso: DosintexDopamine agonist | Drug | Cabergoline |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants Reporting Breast Pain
Time frame: Day 4 after procedure
Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.
3 secondary outcomes
Number of Participants Experiencing Side-effects
Time frame: Cumulative over 2 weeks
Number of Participants Reporting Significant Bother From Breast Pain
Time frame: Day 4 after procedure
Number of Participants Reporting Significant Bother From Side-effects
Time frame: Cumulative over 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41538804Henkel 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.
- Individual participant dataSharing planned: Yes. De-identified data may be requested for meta-analysis inclusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabergoline 1 MG in people with Lactation Suppressed, run by Stanford University at 2 sites 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 14 inclusion and 8 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: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Breast Pain (time frame: Day 4 after procedure). 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 NCT06029673, which also lists 1 linked publication.
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 3 Oct 2025.