The Safety and Efficacy of Recombinant Human Prolactin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00438490
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : April 18, 2013
Last Update Posted : January 3, 2018
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
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
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 

  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
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 
[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% 
[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
No text entered.

  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

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

Responsible Party: Corrine Welt, Massachusetts General Hospital 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