Recombinant Human Prolactin for Lactation Induction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181610
First received: September 9, 2005
Last updated: May 8, 2013
Last verified: May 2013
Results First Received: February 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Lactation
Interventions: Drug: Recombinant Human Prolactin
Biological: Recombinant human prolactin
Biological: Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2004-2008 Academic Hospital, clinical research center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Placebo Twice Per Day

Placebo group

Normal Saline : twice per day

Recombinant Human Prolactin Twice Per Day

Recombinant human prolactin every 12 hours

Recombinant Human Prolactin : 60 mcg/kg every 12 hours

Recombinant Human Prolactin Alternating With Placebo

Recombinant human prolactin alternating with placebo every 12 hours

Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours


Participant Flow:   Overall Study
    Placebo Twice Per Day     Recombinant Human Prolactin Twice Per Day     Recombinant Human Prolactin Alternating With Placebo  
STARTED     4     4     3  
COMPLETED     4     3     3  
NOT COMPLETED     0     1     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One subject did not complete the study and data was not analyzed for that subject.

Reporting Groups
  Description
Placebo Twice Per Day

Placebo group

Normal Saline : twice per day

Recombinant Human Prolactin Twice Per Day

Recombinant human prolactin every 12 hours

Recombinant Human Prolactin : 60 mcg/kg every 12 hours

Recombinant Human Prolactin Once Per Day

Recombinant human prolactin alternating with placebo every 12 hours

Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours

Total Total of all reporting groups

Baseline Measures
    Placebo Twice Per Day     Recombinant Human Prolactin Twice Per Day     Recombinant Human Prolactin Once Per Day     Total  
Number of Participants  
[units: participants]
  4     3     3     10  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     4     3     3     10  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30  ± 5     30  ± 5     32  ± 6     32  ± 5  
Gender  
[units: participants]
       
Female     4     3     3     10  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     4     3     3     10  



  Outcome Measures

1.  Primary:   Breast Milk Production   [ Time Frame: 7 days ]

2.  Secondary:   Breast Milk Volume   [ Time Frame: 7 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Breast Milk Prolactin Levels and Content   [ Time Frame: 7 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Corrine Welt, MD
Organization: Massachusetts General Hospital
phone: 617-726-8437
e-mail: cwelt@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:

Responsible Party: Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181610     History of Changes
Other Study ID Numbers: 2001P001475
Study First Received: September 9, 2005
Results First Received: February 5, 2013
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration