The Safety and Efficacy of Recombinant Human Prolactin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438490
First received: February 20, 2007
Last updated: April 17, 2013
Last verified: April 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, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: Recombinant Human Prolactin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Normal Saline Placebo once daily
Recombinant Human Prolactin Recombinant Human Prolactin 60 mcg/kg once daily

Participant Flow:   Overall Study
    Placebo     Recombinant Human Prolactin  
STARTED     12     9  
COMPLETED     12     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Placebo No text entered.
Recombinant Human Prolactin

RhProlactin once daily

Recombinant Human Prolactin :

Total Total of all reporting groups

Baseline Measures
    Placebo     Recombinant Human Prolactin     Total  
Number of Participants  
[units: participants]
  12     9     21  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     9     21  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.1  ± 4.0     27.9  ± 6.4     28.4  ± 5.4  
Gender  
[units: participants]
     
Female     12     9     21  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     12     9     21  



  Outcome Measures

1.  Primary:   Galactorrhea   [ Time Frame: 7 days ]

2.  Secondary:   Bone Turnover-deoxypyridinoline, N-telopeptide, Bone Specific Alkaline Phosphatase   [ Time Frame: 7 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Menstrual Cycle Length   [ Time Frame: 28 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Reproductive Hormones-LH, FSH, Estradiol   [ Time Frame: 7 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


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


Responsible Party: Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438490     History of Changes
Other Study ID Numbers: 2001-P-001057
Study First Received: February 20, 2007
Results First Received: February 5, 2013
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration