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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 below
Select...
I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days post procedure and two weeks post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post procedure and two weeks post procedure for reporting.

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 • NCT02542410
50%
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
~1300

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
916,887 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Cabergoline put patients at risk?

"The safety of cabergoline has been verified through phase 4 trials, thus receiving a score of 3."

Answered by AI

Are seniors aged 55 or more allowed to participate in this experiment?

"This research is looking for participants of legal age (18+) and younger than 50."

Answered by AI

Would I pass the criteria for joining this experiment?

"To qualify for the trial, applicants must have a lactation index less than 18 and be between eighteen and fifty years old. Altogether, two hundred individuals will partake in this study."

Answered by AI

Are there any available openings to join this clinical trial?

"The information available on clinicaltrials.gov states that this research initiative is no longer actively seeking participants for its study, which was first posted on December 1st 2023 and last updated November 7th 2023. However, at present there are 4 other studies recruiting patients."

Answered by AI
~0 spots leftby Apr 2024