Lactation SuppressedPhase 2LISTA3NCT06909123
A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss
A Phase 2 study testing Cabergoline in people with Lactation Suppressed, run by Stanford University.
Trial summary
Most patients seeking abortion care or management of pregnancy loss in the second trimester will lactate, which can be physically and emotionally painful. The efficacy of a one-time dose of cabergoline has been previously demonstrated to prevent breast symptoms for these patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Lactation Suppressed
- What is being tested?
- Cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant people, ages 18 years or older
- Intrauterine pregnancy between 16/0-25/6 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
- Access to smart phone throughout study
Who cannot join
- 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
About this study
Most patients seeking abortion care or management of pregnancy loss in the second trimester will lactate, which can be physically and emotionally painful. The efficacy of a one-time dose of cabergoline has been previously demonstrated to prevent breast symptoms for these patients. This study seeks to determine if investigators can more precisely manage these patients with a reduced dose appropriate for the physiology of the second trimester, thereby reducing the medication cost and reducing or eliminating the uncomfortable medication side effects.
Read the detailed description
Most people do not expect breast engorgement following a second-trimester pregnancy loss yet nearly all report bothersome symptoms. Prolactin is the primary hormone responsible for milk production. The dopamine agonist class, including cabergoline, prevents prolactin release, leading to lactation inhibition. Based on dose-finding studies after a full-term birth, a one-time dose of cabergoline 1 mg is offered for lactation inhibition for full-term fetal/neonatal loss or for those with contraindications to breastfeeding.
Recently, our own research found a single dose of cabergoline 1 mg effectively prevents breast symptoms after a second-trimester abortion or stillbirth. However, cabergoline is relatively expensive and associated with side effects such as dizziness, headache, and nausea.
As serum prolactin levels are much lower in the second trimester, it is plausible that a lower dose of cabergoline may still be effective in preventing lactation following a second-trimester loss. Our overarching hypothesis is that a lower dose of cabergoline given after a second-trimester abortion or pregnancy loss will still prevent breast symptoms while also decreasing the frequency and severity of side effects. A lower dose would additionally save money for the healthcare system and patient. For this pilot study, we first plan to test whether a lower dose of cabergoline can reduce serum prolactin levels to physiologic levels.
This is a pilot double-blinded, gestational-age stratified trial of those with fetal demise, stillbirth, or seeking abortion care between 16- and 26-weeks gestation. The investigators will determine if the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level on Day 4 is non-inferior to those receiving cabergoline 1 mg.
- Conditions
- Lactation Suppressed
- Being tested
- Cabergoline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
Also called Dostinex
Cabergoline
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline 1 mg tab | Active 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 cabergoline 1mg orally with juice or water by the clinician or study investigator. Receives: Drug: Cabergoline |
| Cabergoline 0.5 mg tab | 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 0.5mg orally with juice or water by the clinician or study investigator. Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with serum prolactin level less than 23 ng/mL
Comparison of the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level (defined as less than 23ng/mL) to those receiving cabergoline 1 mg
Measured: Day 4
Secondary outcomes (1)
Number of participants with breast symptoms
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909123
- Sponsor's protocol ID
- 80200
- Acronym
- LISTA3
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss
- ClinicalTrials.gov ID
- NCT06909123
- Acronym / sponsor ID
- LISTA3 / 80200
- Conditions
- Lactation Suppressed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most patients seeking abortion care or management of pregnancy loss in the second trimester will lactate, which can be physically and emotionally painful. The efficacy of a one-time dose of cabergoline has been previously demonstrated to prevent breast symptoms for these patients. This study seeks to determine if investigators can more precisely manage these patients with a reduced dose appropriate for the physiology of the second trimester, thereby reducing the medication cost and reducing or eliminating the uncomfortable medication side effects.
Detailed description
Most people do not expect breast engorgement following a second-trimester pregnancy loss yet nearly all report bothersome symptoms. Prolactin is the primary hormone responsible for milk production. The dopamine agonist class, including cabergoline, prevents prolactin release, leading to lactation inhibition. Based on dose-finding studies after a full-term birth, a one-time dose of cabergoline 1 mg is offered for lactation inhibition for full-term fetal/neonatal loss or for those with contraindications to breastfeeding.
Recently, our own research found a single dose of cabergoline 1 mg effectively prevents breast symptoms after a second-trimester abortion or stillbirth. However, cabergoline is relatively expensive and associated with side effects such as dizziness, headache, and nausea.
As serum prolactin levels are much lower in the second trimester, it is plausible that a lower dose of cabergoline may still be effective in preventing lactation following a second-trimester loss. Our overarching hypothesis is that a lower dose of cabergoline given after a second-trimester abortion or pregnancy loss will still prevent breast symptoms while also decreasing the frequency and severity of side effects. A lower dose would additionally save money for the healthcare system and patient. For this pilot study, we first plan to test whether a lower dose of cabergoline can reduce serum prolactin levels to physiologic levels.
This is a pilot double-blinded, gestational-age stratified trial of those with fetal demise, stillbirth, or seeking abortion care between 16- and 26-weeks gestation. The investigators will determine if the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level on Day 4 is non-inferior to those receiving cabergoline 1 mg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabergoline 1 mg tab | Active comparator | Drug: CabergolineAfter 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. |
| Cabergoline 0.5 mg tab | Experimental | Drug: CabergolineAfter the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 0.5mg orally with juice or water by the clinician or study investigator. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant people, ages 18 years or older
- Intrauterine pregnancy between 16/0-25/6 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 (7 listed)
- 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)
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 |
|---|---|---|
| CabergolineAlso: DostinexCabergoline | Drug | Cabergoline 0.5 mg tab, Cabergoline 1 mg tab |
Primary outcome
Number of participants with serum prolactin level less than 23 ng/mL
Time frame: Day 4
Comparison of the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level (defined as less than 23ng/mL) to those receiving cabergoline 1 mg
1 secondary outcome
Number of participants with breast symptoms
Time frame: Day 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabergoline in people with Lactation Suppressed, run by Stanford University.
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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 with serum prolactin level less than 23 ng/mL (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.