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The Safety and Efficacy of Recombinant Human Prolactin

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ClinicalTrials.gov Identifier: NCT00438490
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : April 18, 2013
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: Recombinant Human Prolactin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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 
Overall Participants Analyzed 
[Units: Participants]
 12   9   21 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12 100.0%      9 100.0%      21 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.1  (4.0)   27.9  (6.4)   28.4  (5.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12 100.0%      9 100.0%      21 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   12   9   21 


  Outcome Measures

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

2.  Secondary:   N-telopeptide   [ Time Frame: 7 days ]

3.  Secondary:   Menstrual Cycle Length   [ Time Frame: 28 days ]

4.  Secondary:   Estradiol   [ Time Frame: 7 days ]


  Serious Adverse Events


  Other Adverse Events


  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
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  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438490     History of Changes
Other Study ID Numbers: 2001-P-001057
First Submitted: February 20, 2007
First Posted: February 22, 2007
Results First Submitted: February 5, 2013
Results First Posted: April 18, 2013
Last Update Posted: January 3, 2018