A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss

NCT06909123 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 80200
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Lactation Suppressed

Outcome Measures

Primary Outcomes (1)

• 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

  Day 4

Secondary Outcomes (1)

• Number of participants with breast symptoms

  Day 4

Study Arms (2)

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.

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.

Drug: Cabergoline

Interventions

Cabergoline DRUG

Cabergoline

Also known as: Dostinex

Cabergoline 0.5 mg tab; Cabergoline 1 mg tab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Interventions

Cabergoline

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share