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Cabergoline for Post-Abortion Lactation
Phase 4
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18 to 50
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days post procedure and two weeks post procedure
Awards & highlights
Study Summary
This trial will compare breast symptoms of those who undergo a procedure for second trimester pregnancy loss between 16-20 weeks. Participants randomly take either a placebo or a medication, with researchers comparing results.
Who is the study for?
This trial is for pregnant individuals aged 18-50 seeking to end a pregnancy between 16 and nearly 20 weeks, who can consent in English. It's not for those under 18 or over 50, past the gestational age limit, with hypertension issues, heart valve disorders, pulmonary fibrosis, severe mental health conditions like bipolar schizophrenia, or allergies including lactose intolerance.Check my eligibility
What is being tested?
The study tests if cabergoline reduces breast symptoms after abortion at 16-20 weeks compared to a placebo. Participants are randomly given either cabergoline or a placebo tablet immediately following their procedure to see if there's a difference in symptoms like lactation and engorgement.See study design
What are the potential side effects?
Cabergoline may cause side effects such as nausea, headache, dizziness, low blood pressure upon standing up (orthostatic hypotension), and possibly stomach pain. The severity of these side effects can vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days post procedure and two weeks post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days post procedure and two weeks post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
breast symptoms
Side effects data
From 2018 Phase 2 trial • 10 Patients • NCT0254241050%
IRREGULAR VAGINAL BLEEDING
25%
NAUSEA
25%
FATIGUE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Experimental
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CabergolineExperimental Treatment1 Intervention
1mg oral cabergoline administered once after patient's procedure
Group II: PlaceboPlacebo Group1 Intervention
1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabergoline
2021
Completed Phase 4
~1710
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,604 Previous Clinical Trials
915,979 Total Patients Enrolled
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