LactationPhase 2NCT00181649
Recombinant Human Prolactin for Lactation Induction
A Phase 2 study testing Recombinant human prolactin in people with Lactation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Lactation
- What is being tested?
- Recombinant human prolactin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2011
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy, non-postpartum women, aged 18-45 years, who desire to lactate for their adoptive children
- Normal thyroid-stimulating hormone (TSH) and prolactin level
- Normal adrenal gland function or taking physiological glucocorticoid replacement
- No medical illnesses that contraindicate breastfeeding
- HIV negative
- Normal breast development
Who cannot join
- Use of medications known to increase prolactin
- Anatomical breast abnormalities
- Previous mammoplasty or breast augmentation
- Current use of hormonal contraception
- Allergies to mannitol
- Medications contraindicated for breastfeeding mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Recombinant Human Prolactin for Lactation Induction in Adoptive Mothers
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Read the detailed description
Subjects will participate in a randomized, double-blind, placebo-controlled, crossover trial comparing breast pumping, alone, to breast pumping and r-hPRL. Subjects will have one week of instruction with the breast pump alone. Subsequently, subjects will receive 2 weeks of r-hPRL or placebo followed by 2 weeks of the alternate treatment.
Week 1: Study day 1, a baseline prolactin level will be obtained and subjects will be taught to use an electrical, hospital grade breast pump by a designated lactation consultant. Subjects will pump for 10 minutes at each breast. The total volume of milk will be recorded in a diary throughout the study. Prolactin levels will be obtained every 10 minutes for 60 minutes after pumping begins, then every 30 minutes for a total of 3 hours. Subjects will pump 3 times per day increasing to 8 times per day by the end of the first week and will continue this regimen throughout the study.
Week 2: One week after the initial visit, subjects will return to the GCRC for re-evaluation of the pumping technique and the first dose of medication. Subjects will pump for 10 minutes at each breast as on day 1 and prolactin levels will be obtained every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. At 3 hours, r-hPRL 60 mg/kg or placebo will be administered SC. Blood will be drawn every 10 minutes for 60 minutes, every 30 minutes for 2 hours, then at 4, 6 and 8 hours to obtain a peak prolactin level. Vital signs will be monitored every 15 minutes for the first hour, then every 2 hours for a total of 8 hours. Subjects will pump both breasts every 3 hours, starting after the r-hPRL or placebo injection. Subjects will be taught to give themselves SC injections and will administer their second dose of SC r-hPRL or placebo 12 hours after the first dose. Subjects will continue SC r-hPRL or placebo administration every 12 hours for the next 14 days. They will continue to pump daily, approximately every 3 hours, with a 5 hour break in the night to sleep. Subjects will be asked to refrigerate all milk and bring it in to GCRC visits for prolactin levels.
Subjects will return weekly for 4 additional visits (weeks 3, 4, 5, 6). At the weekly visits, blood will be drawn at baseline for a prolactin level and r-hPRL or placebo will be administered. Blood will then be drawn every 10 minutes for 60 minutes, then every 30 minutes for 2 hours, then every 2 hours for a total of 8 hours after the injection. Vital signs will be monitored as described above. At the week 4 visit, subjects will be switched to the alternate treatment for weeks 4 and 5. Subjects will be seen 14 days after their final injection. A baseline prolactin level will be drawn, then milk will be pumped, as previously. Blood will be drawn every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. A 1 cc sample of the milk will also be obtained 14 days after the final injection for analysis of composition. All side effects of r-hPRL will be recorded throughout the study. All milk obtained during the study will be stored and the milk composition will be determined before it is used. Infants receiving milk produced during the study will initially be monitored in the GCRC under the supervision of a neonatologist.
- Conditions
- Lactation
- Being tested
- Recombinant human prolactin
- Keywords
- Lactation, Breastfeeding, Adoptive mothers, Prolactin, Relative lactation insufficiency
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human prolactinDrug
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human prolactin | Experimental | Not described Receives: Drug: Recombinant human prolactin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk production
Measured: 28 days
Secondary outcomes (2)
Breast milk volume
Measured: 28 days
Breast milk prolactin levels and content
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2006
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Not able to recruit any subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrine Welt, Massachusetts General Hospital
- Investigators
- Corrine K Welt, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181649
- Sponsor's protocol ID
- 2003P001209-2
- Status last verified
- May 2013
- First submitted
- 9 Sep 2005
- Last updated
- 9 May 2013
- Results posted
- No
Publications
Powe CE, Puopolo KM, Newburg DS, Lonnerdal B, Chen C, Allen M, Merewood A, Worden S, Welt CK. Effects of recombinant human prolactin on breast milk composition. Pediatrics. 2011 Feb;127(2):e359-66. doi: 10.1542/peds.2010-1627. Epub 2011 Jan 24.
PubMed 21262884Powe CE, Allen M, Puopolo KM, Merewood A, Worden S, Johnson LC, Fleischman A, Welt CK. Recombinant human prolactin for the treatment of lactation insufficiency. Clin Endocrinol (Oxf). 2010 Nov;73(5):645-53. doi: 10.1111/j.1365-2265.2010.03850.x.
PubMed 20718766
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Prolactin for Lactation Induction in Adoptive Mothers
- ClinicalTrials.gov ID
- NCT00181649
- Acronym / sponsor ID
- 2003P001209-2
- Conditions
- Lactation
- Keywords
- Lactation, Breastfeeding, Adoptive mothers, Prolactin, Relative lactation insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to recruit any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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.
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Detailed description
Subjects will participate in a randomized, double-blind, placebo-controlled, crossover trial comparing breast pumping, alone, to breast pumping and r-hPRL. Subjects will have one week of instruction with the breast pump alone. Subsequently, subjects will receive 2 weeks of r-hPRL or placebo followed by 2 weeks of the alternate treatment.
Week 1: Study day 1, a baseline prolactin level will be obtained and subjects will be taught to use an electrical, hospital grade breast pump by a designated lactation consultant. Subjects will pump for 10 minutes at each breast. The total volume of milk will be recorded in a diary throughout the study. Prolactin levels will be obtained every 10 minutes for 60 minutes after pumping begins, then every 30 minutes for a total of 3 hours. Subjects will pump 3 times per day increasing to 8 times per day by the end of the first week and will continue this regimen throughout the study.
Week 2: One week after the initial visit, subjects will return to the GCRC for re-evaluation of the pumping technique and the first dose of medication. Subjects will pump for 10 minutes at each breast as on day 1 and prolactin levels will be obtained every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. At 3 hours, r-hPRL 60 mg/kg or placebo will be administered SC. Blood will be drawn every 10 minutes for 60 minutes, every 30 minutes for 2 hours, then at 4, 6 and 8 hours to obtain a peak prolactin level. Vital signs will be monitored every 15 minutes for the first hour, then every 2 hours for a total of 8 hours. Subjects will pump both breasts every 3 hours, starting after the r-hPRL or placebo injection. Subjects will be taught to give themselves SC injections and will administer their second dose of SC r-hPRL or placebo 12 hours after the first dose. Subjects will continue SC r-hPRL or placebo administration every 12 hours for the next 14 days. They will continue to pump daily, approximately every 3 hours, with a 5 hour break in the night to sleep. Subjects will be asked to refrigerate all milk and bring it in to GCRC visits for prolactin levels.
Subjects will return weekly for 4 additional visits (weeks 3, 4, 5, 6). At the weekly visits, blood will be drawn at baseline for a prolactin level and r-hPRL or placebo will be administered. Blood will then be drawn every 10 minutes for 60 minutes, then every 30 minutes for 2 hours, then every 2 hours for a total of 8 hours after the injection. Vital signs will be monitored as described above. At the week 4 visit, subjects will be switched to the alternate treatment for weeks 4 and 5. Subjects will be seen 14 days after their final injection. A baseline prolactin level will be drawn, then milk will be pumped, as previously. Blood will be drawn every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. A 1 cc sample of the milk will also be obtained 14 days after the final injection for analysis of composition. All side effects of r-hPRL will be recorded throughout the study. All milk obtained during the study will be stored and the milk composition will be determined before it is used. Infants receiving milk produced during the study will initially be monitored in the GCRC under the supervision of a neonatologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant human prolactin | Experimental | Drug: Recombinant human prolactin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, non-postpartum women, aged 18-45 years, who desire to lactate for their adoptive children
- Normal thyroid-stimulating hormone (TSH) and prolactin level
- Normal adrenal gland function or taking physiological glucocorticoid replacement
- No medical illnesses that contraindicate breastfeeding
- HIV negative
Key exclusion criteria (6 listed)
- Use of medications known to increase prolactin
- Anatomical breast abnormalities
- Previous mammoplasty or breast augmentation
- Current use of hormonal contraception
- Allergies to mannitol
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 |
|---|---|---|
| Recombinant human prolactin | Drug | Recombinant human prolactin |
Primary outcome
Breast milk production
Time frame: 28 days
2 secondary outcomes
Breast milk volume
Time frame: 28 days
Breast milk prolactin levels and content
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2013.
- Results publication: PubMed 21262884Powe CE, Puopolo KM, Newburg DS, Lonnerdal B, Chen C, Allen M, Merewood A, Worden S, Welt CK. Effects of recombinant human prolactin on breast milk composition. Pediatrics. 2011 Feb;127(2):e359-66. doi: 10.1542/peds.2010-1627. Epub 2011 Jan 24.
- Results publication: PubMed 20718766Powe CE, Allen M, Puopolo KM, Merewood A, Worden S, Johnson LC, Fleischman A, Welt CK. Recombinant human prolactin for the treatment of lactation insufficiency. Clin Endocrinol (Oxf). 2010 Nov;73(5):645-53. doi: 10.1111/j.1365-2265.2010.03850.x.
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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.
Corrine K Welt, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human prolactin in people with Lactation, run by Massachusetts General Hospital at 1 site in United States.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 May 2013. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Breast milk production (time frame: 28 days). 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 NCT00181649, which also lists 2 linked publications.
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 9 May 2013; AzTrials last refreshed its copy on 28 Oct 2026.