Lactation SuppressedNCT05024422
Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline
A study testing Cabergoline and Pyridoxine in people with Lactation Suppressed, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. 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
- What is being tested?
- Cabergoline and Pyridoxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2021to 7 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Postpartum women who are interested in pharmacologic lactation suppression
- Women over the age of 18
Who cannot join
- Women with known sensitivity to vitamin B6 or Cabergoline
- Women with hypertensive Disorders or contraindication to Cabergoline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial
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:
Read more
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:
- Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
- 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.
- Conditions
- Lactation Suppressed
- Being tested
- Cabergoline, Pyridoxine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
PyridoxineDrug
Also called Vitamin B6
Administration of Pyridoxine (200 mg X 3 per day for a week)
| Study group | Role | What they receive |
|---|---|---|
| Administration of Cabergoline | Active comparator | one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days Receives: Drug: Cabergoline |
| Administration of Vitamin B6 | Active comparator | 200 mg X 3 per day for a week Receives: Drug: Pyridoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactation suppression
Measured: 7 days
reduction of congestion
Measured: 14 days
cessation of milk leakage
Measured: 14 days
cessation of breast pain
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start31 Dec 2021
- Primary completion1 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lactation SuppressedStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024422
- Sponsor's protocol ID
- 0053-21
- Status last verified
- Nov 2022
- First submitted
- 23 Aug 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dayan-Schwartz A, Yefet E, Massalha M, Hosari-Mhameed S, Remer-Gross C, Pasand E, Nachum Z. The efficiency of cabergoline vs pyridoxine for lactation inhibition-a randomized controlled trial. Am J Obstet Gynecol. 2024 May;230(5):561.e1-561.e8. doi: 10.1016/j.ajog.2023.10.009. Epub 2023 Oct 11.
PubMed 37827268
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05024422
- Acronym / sponsor ID
- 0053-21
- Conditions
- Lactation Suppressed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Cabergoline | Active comparator | Drug: Cabergolineone dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days |
| Administration of Vitamin B6 | Active comparator | Drug: Pyridoxine200 mg X 3 per day for a week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Postpartum women who are interested in pharmacologic lactation suppression
- Women over the age of 18
Key exclusion criteria (2 listed)
- Women with known sensitivity to vitamin B6 or Cabergoline
- Women with hypertensive Disorders or contraindication to Cabergoline.
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 |
|---|---|---|
| CabergolineAdministration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days) | Drug | Administration of Cabergoline |
| PyridoxineAlso: Vitamin B6Administration of Pyridoxine (200 mg X 3 per day for a week) | Drug | Administration of Vitamin B6 |
Primary outcome
Lactation suppression
Time frame: 7 days
reduction of congestion
Time frame: 14 days
cessation of milk leakage
Time frame: 14 days
cessation of breast pain
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 37827268Dayan-Schwartz A, Yefet E, Massalha M, Hosari-Mhameed S, Remer-Gross C, Pasand E, Nachum Z. The efficiency of cabergoline vs pyridoxine for lactation inhibition-a randomized controlled trial. Am J Obstet Gynecol. 2024 May;230(5):561.e1-561.e8. doi: 10.1016/j.ajog.2023.10.009. Epub 2023 Oct 11.
- Individual participant dataSharing planned: Undecided
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 study testing Cabergoline and Pyridoxine in people with Lactation Suppressed, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 2 inclusion and 2 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 14 Nov 2022. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lactation suppression (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024422, which also lists 1 linked publication.
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 14 Nov 2022.