Lactation SuppressedPhase 4NCT06123026
Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion
A Phase 4 study testing Cabergoline in people with Lactation Suppressed and Second Trimester Abortion, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Suppressed, Second Trimester 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to 30 Jun 2024
- Phase
- Phase 4
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant individuals seeking termination of pregnancy after 16w0d gestation and up to 19w6d gestation. this includes management of intrauterine demises
- ages 18 to 50
- con provide informed consent in English
Who cannot join
- Age under 18 or above 50
- gestational ages before 16 weeks 0 days or after 20 weeks 0 days
- unable to provide written consent in English
- hypertensive disorder
- uncontrolled hypertension or known hypersensitivity to ergot derivatives
- History of cardiac valvular disorders
Show all 9Show fewer
- history of pulmonary fibrosis
- documented bipolar schizophrenia
- documented allergy to medication, including lactose intolerance (placebo pill involves lactose)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Center
Chicago, Illinois, 60611
About this study
Official title: Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion: a Randomized Controlled Trial
The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called "cabergoline" which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.
- Conditions
- Lactation Suppressed, Second Trimester Abortion
- Being tested
- Cabergoline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
1mg oral cabergoline given to participants once
PlaceboDrug
1 encapsulated placebo tablet given to participants after procedure
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline | Experimental | 1mg oral cabergoline administered once after patient's procedure Receives: Drug: Cabergoline |
| Placebo | Placebo comparator | 1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Breast Questionnaire
Bristol Breast Questionnaire is a patient-reported outcome measure developed to assess the impact of breast surgery on:
It has 4 items (engorgement, tenderness, leakage/secretions, means used to obtain relief) scored 0-3 Engorgement scored: 0 (no engorgement) 1 (beginning to fill) 2 (breasts feel full) 3 (skin tight/swelling) Tenderness scored: 0 (no tenderness) 1 (tender with touch) 2 (tender without touch) 3 (tender despite medication) Leakage/secretions scored: 0 (no leakage) 1 (drops/spotting only) 2 (periodic free flow) 3 (requires pas/change of bra) Means Used to Obtain Relief scored 0 (nothing/supportive bra only) 1 (ice/cold therapy) 2 (over the counter medication) 3 (over the counter medication + prescribed opioid) Total score 0-12 Higher score indicates greater severity. Data reported is change between 3 days post procedure and two weeks post procedure.
Measured: 3 days post procedure and two weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start18 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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.
- Other trials for Lactation SuppressedStudies of the same condition, open and under way.
- More trials run by Northwestern 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123026
- Sponsor's protocol ID
- STU00218555
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2023
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06123026
- Acronym / sponsor ID
- STU00218555
- Conditions
- Lactation Suppressed, Second Trimester Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called "cabergoline" which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabergoline | Experimental | Drug: Cabergoline1mg oral cabergoline administered once after patient's procedure |
| Placebo | Placebo comparator | Drug: Placebo1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant individuals seeking termination of pregnancy after 16w0d gestation and up to 19w6d gestation. this includes management of intrauterine demises
- ages 18 to 50
- con provide informed consent in English
Key exclusion criteria (9 listed)
- Age under 18 or above 50
- gestational ages before 16 weeks 0 days or after 20 weeks 0 days
- unable to provide written consent in English
- hypertensive disorder
- uncontrolled hypertension or known hypersensitivity to ergot derivatives
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 |
|---|---|---|
| Cabergoline1mg oral cabergoline given to participants once | Drug | Cabergoline |
| Placebo1 encapsulated placebo tablet given to participants after procedure | Drug | Placebo |
Primary outcome
Bristol Breast Questionnaire
Time frame: 3 days post procedure and two weeks post procedure
Bristol Breast Questionnaire is a patient-reported outcome measure developed to assess the impact of breast surgery on: It has 4 items (engorgement, tenderness, leakage/secretions, means used to obtain relief) scored 0-3 Engorgement scored: 0 (no engorgement) 1 (beginning to fill) 2 (breasts feel full) 3 (skin tight/swelling) Tenderness scored: 0 (no tenderness) 1 (tender with touch) 2 (tender without touch) 3 (tender despite medication) Leakage/secretions scored: 0 (no leakage) 1 (drops/spotting only) 2 (periodic free flow) 3 (requires pas/change of bra) Means Used to Obtain Relief scored 0 (nothing/supportive bra only) 1 (ice/cold therapy) 2 (over the counter medication) 3 (over the counter medication + prescribed opioid) Total score 0-12 Higher score indicates greater severity. Data reported is change between 3 days post procedure and two weeks post procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cabergoline in people with Lactation Suppressed and Second Trimester Abortion, run by Northwestern University 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 3 inclusion and 9 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 15 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 15 Oct 2026). 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?
Bristol Breast Questionnaire (time frame: 3 days post procedure and two weeks post procedure). 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 15 Oct 2026.