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Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

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ClinicalTrials.gov Identifier: NCT05024422
Recruitment Status : Completed
First Posted : August 27, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:

Some mothers may seek lactation suppression on personal, social, or medical grounds. To reduce congestion symptoms and shorten the duration of milk production lactation suppression can be done pharmacologic or non-pharmacologic. The most common drug for this purpose is Cabergoline, a dopaminergic agonist, that has significant side effects. Cabergoline is not approved for use in patients with hypertensive disorders, fibrotic diseases, heart problems or liver disease. Vitamin B6 has also been studied for this indication with no significant side effects. All those studies conducted before 1980. There is no current literature on the subject. There are no studies comparing Cabergoline to Vitamin B6 for this indication.

Purpose:

The aim of this study is to test whether Cabergoline is more effective than vitamin B6 for lactation suppression.

method: A prospective randomized study in the maternity ward at Haemek medical center in Afula, Israel.

Postpartum women without contraindication to any one of the treatments, who are interested in a pharmaceutical induced lactation suppression will be divided into two randomized groups:

  1. Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
  2. Administration of Vitamin B6 (200 mg X 3 per day for a week)

All women will answer a questionnaire to assess breast congestion, milk leakage and breast pain on days 0, 2, 7 and 14.


Condition or disease Intervention/treatment Phase
Lactation Suppressed Drug: Cabergoline Drug: Pyridoxine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial
Actual Study Start Date : December 31, 2021
Actual Primary Completion Date : November 1, 2022
Actual Study Completion Date : November 7, 2022


Arm Intervention/treatment
Active Comparator: Administration of Cabergoline
one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days
Drug: Cabergoline
Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)

Active Comparator: Administration of Vitamin B6
200 mg X 3 per day for a week
Drug: Pyridoxine
Administration of Pyridoxine (200 mg X 3 per day for a week)
Other Name: Vitamin B6




Primary Outcome Measures :
  1. Lactation suppression [ Time Frame: 7 days ]
  2. reduction of congestion [ Time Frame: 14 days ]
  3. cessation of milk leakage [ Time Frame: 14 days ]
  4. cessation of breast pain [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Postpartum women who are interested in pharmacologic lactation suppression
  2. Women over the age of 18

Exclusion Criteria:

  1. Women with known sensitivity to vitamin B6 or Cabergoline
  2. Women with hypertensive Disorders or contraindication to Cabergoline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024422


Locations
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Israel
HaEmek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT05024422    
Other Study ID Numbers: 0053-21
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin B 6
Pyridoxine
Cabergoline
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action