HealthyPhase 2NCT00438490
The Safety and Efficacy of Recombinant Human Prolactin
A Phase 2 study testing Recombinant Human Prolactin in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Recombinant Human Prolactin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Subjects will meet the following criteria:
- 18 to 40 years of age
- Normal weight (BMI 17 to £ 30 kg/m2)
- Good general health
- On no medications for at least 3 months before the study
- Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
Show all 14Show fewer
- No evidence of androgen excess
- Normal TSH, prolactin and hematocrit
- No current interest in conception
- No history of osteoporosis
- No use of medications known to affect bone turnover
- No alcoholism
- No smoking
- No history of medical problems or treatment known to affect bone turnover.
Who cannot join
- Subjects will be excluded for pregnancy or evidence of breast masses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.
Read the detailed description
There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.
- Conditions
- Healthy
- Being tested
- Recombinant Human Prolactin
- Keywords
- galactorrhea, prolactin, bone turnover, menstrual cycle, Control Groups, Women
- Medical subject headings
- Galactorrhea
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 | Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection Receives: Drug: Recombinant Human Prolactin |
| Placebo | Placebo comparator | Normal saline placebo subcutaneous injection Receives: Drug: Recombinant Human Prolactin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galactorrhea
Galactorrhea is breast milk production.
Measured: 7 days
Secondary outcomes (3)
N-telopeptide
Measured: 7 days
Menstrual Cycle Length
Measured: 28 days
Estradiol
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startApr 2002
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 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
- NCT00438490
- Sponsor's protocol ID
- 2001-P-001057
- Status last verified
- Dec 2017
- First submitted
- 20 Feb 2007
- Last updated
- 3 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Page-Wilson G, Smith PC, Welt CK. Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent. Int Breastfeed J. 2007 Jul 24;2:10. doi: 10.1186/1746-4358-2-10.
PubMed 17650319
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety
- ClinicalTrials.gov ID
- NCT00438490
- Acronym / sponsor ID
- 2001-P-001057
- Conditions
- Healthy
- Keywords
- galactorrhea, prolactin, bone turnover, menstrual cycle, Control Groups, Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Posted 18 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.
Detailed description
There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recombinant human prolactin | Experimental | Drug: Recombinant Human ProlactinRecombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection |
| Placebo | Placebo comparator | Drug: Recombinant Human ProlactinNormal saline placebo subcutaneous injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 18 to 40 years of age
- Normal weight (BMI 17 to £ 30 kg/m2)
- Good general health
- On no medications for at least 3 months before the study
- Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
Key exclusion criteria (1 listed)
- Subjects will be excluded for pregnancy or evidence of breast masses.
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 | Placebo, recombinant human prolactin |
Primary outcome
Galactorrhea
Time frame: 7 days
Galactorrhea is breast milk production.
3 secondary outcomes
N-telopeptide
Time frame: 7 days
Menstrual Cycle Length
Time frame: 28 days
Estradiol
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17650319Page-Wilson G, Smith PC, Welt CK. Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent. Int Breastfeed J. 2007 Jul 24;2:10. doi: 10.1186/1746-4358-2-10.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Healthy, 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 14 inclusion and 1 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 3 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Galactorrhea (time frame: 7 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 NCT00438490, 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 3 Jan 2018.