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Study of Leptin for the Treatment of Hypothalamic Amenorrhea

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Amgen
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00130117
First received: August 11, 2005
Last updated: April 13, 2017
Last verified: April 2017
Results First Received: December 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider;   Primary Purpose: Treatment
Condition: Amenorrhea
Interventions: Drug: r-metHuLeptin
Drug: Oral Contraceptive Pills (OCPs)
Other: Placebo

  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
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
r-metHuLeptin

r-metHuLeptin administered subcutaneously.

r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.

Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.

Placebo

placebo

Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.

Placebo: placebo (no active medication)


Participant Flow:   Overall Study
    r-metHuLeptin   Placebo
STARTED   11   9 
COMPLETED   7   6 
NOT COMPLETED   4   3 



  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.
No text entered.

Reporting Groups
  Description
r-metHuLeptin

r-metHuLeptin administered subcutaneously.

r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.

Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.

Placebo

placebo

Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.

Placebo: placebo (no active medication)

Total Total of all reporting groups

Baseline Measures
   r-metHuLeptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   9   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      11 100.0%      9 100.0%      20 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.6  (1.4)   25.4  (1.2)   26  (1.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11 100.0%      9 100.0%      20 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   11   9   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   the Difference Between the Placebo and Leptin Treated Groups in the Change in Bone Mineral Content(BMC) at the Anteroposterior (AP) Spine From Baseline to 36 Weeks   [ Time Frame: 36 weeks ]

2.  Secondary:   Bone Markers - Ctx and Sclerostin   [ Time Frame: 36 weeks ]

3.  Secondary:   Body Composition BMI   [ Time Frame: 36 weeks ]

4.  Secondary:   Total Body BMD   [ Time Frame: 36 weeks ]

5.  Secondary:   Body Fat   [ Time Frame: 36 weeks ]

6.  Secondary:   Total Body BMD   [ Time Frame: 9 months ]

7.  Secondary:   Lumbar BMD   [ Time Frame: 9 months ]

8.  Secondary:   Radial BMD   [ Time Frame: 9 months ]

9.  Secondary:   Hip BMD   [ Time Frame: 9months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Number of participants was small and, therefore, our observations need to be validated in studies with larger sample sizes.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christos Mantzoros
Organization: BIDMC
phone: 6176678630
e-mail: cmantzor@bidmc.harvard.edu


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


Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00130117     History of Changes
Other Study ID Numbers: 2004P000123
1R34HD048526-01 ( US NIH Grant/Contract Award Number )
5M01RR001032-32 ( US NIH Grant/Contract Award Number )
Study First Received: August 11, 2005
Results First Received: December 24, 2015
Last Updated: April 13, 2017