ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 31 for:    Metreleptin

Study of Leptin for the Treatment of Hypothalamic Amenorrhea

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.
ClinicalTrials.gov Identifier: NCT00130117
Recruitment Status : Completed
First Posted : August 15, 2005
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Amenorrhea
Interventions Drug: r-metHuLeptin
Drug: Oral Contraceptive Pills (OCPs)
Other: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description

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

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

Placebo: placebo (no active medication)

Period Title: Overall Study
Started 11 9
Completed 7 6
Not Completed 4 3
Arm/Group Title r-metHuLeptin Placebo Total
Hide Arm/Group Description

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

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

Placebo: placebo (no active medication)

Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
26.6  (1.4) 25.4  (1.2) 26  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
11
 100.0%
9
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 9 participants 20 participants
11 9 20
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 7 6
Mean (Full Range)
Unit of Measure: g
51.0
(43.4 to 58.2)
58.2
(55.2 to 61.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-metHuLeptin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection r-metHuLeptin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Bone Markers - Ctx and Sclerostin
Hide Description [Not Specified]
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only for subjects participating in both phase A and phase B (n=4), bone markers were assessed to see the change over 24 month period. All these patient got metreleptin treatment
Arm/Group Title r-metHuLeptin
Hide Arm/Group Description:

r-metHuLeptin administered subcutaneously.

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

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

Overall Number of Participants Analyzed 4
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
CTX
0.60
(0.39 to 0.83)
Sclerostin
0.08
(0.07 to 0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection r-metHuLeptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments p value reflects treatment of leptin for "on-treatment", n=4
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.60
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Body Composition BMI
Hide Description [Not Specified]
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 7 6
Mean (Standard Error)
Unit of Measure: BMI-kg/m^2
20.8  (0.6) 21.1  (0.6)
4.Secondary Outcome
Title Total Body BMD
Hide Description [Not Specified]
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 7 6
Median (Inter-Quartile Range)
Unit of Measure: g/cm^2
1.07
(1.05 to 1.16)
1.13
(1.09 to 1.23)
5.Secondary Outcome
Title Body Fat
Hide Description [Not Specified]
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 7 6
Mean (Standard Error)
Unit of Measure: fat %
23.9  (1.4) 20.8  (1.3)
6.Secondary Outcome
Title Total Body BMD
Hide Description [Not Specified]
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Oral Contraceptive Pills (OCPs)
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: g/cm2
1.09
(1.06 to 1.15)
1.13
(1.10 to 1.23)
7.Secondary Outcome
Title Lumbar BMD
Hide Description [Not Specified]
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: g/cm2
0.92
(0.80 to 1.03)
0.97
(0.90 to 1.01)
8.Secondary Outcome
Title Radial BMD
Hide Description [Not Specified]
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: g/cm2
0.54
(0.52 to 0.60)
0.54
(0.53 to 0.56)
9.Secondary Outcome
Title Hip BMD
Hide Description [Not Specified]
Time Frame 9months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description:

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

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

Placebo: placebo (no active medication)

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: g/cm2
0.89
(0.80 to 1.03)
0.88
(0.80 to 1.02)
Time Frame [Not Specified]
Adverse Event Reporting Description 11 participants started on the metreleptin arm , although only 7 finished the study. hence participants at risk are 11
 
Arm/Group Title r-metHuLeptin Placebo
Hide Arm/Group Description

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

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

Placebo: placebo (no active medication)

All-Cause Mortality
r-metHuLeptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
r-metHuLeptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
r-metHuLeptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      0/6 (0.00%)    
Skin and subcutaneous tissue disorders     
local injection site reactions with erythematous rashes *  2/11 (18.18%)  2 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Number of participants was small and, therefore, our observations need to be validated in studies with larger sample sizes.
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
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 ( U.S. NIH Grant/Contract )
5M01RR001032-32 ( U.S. NIH Grant/Contract )
First Submitted: August 11, 2005
First Posted: August 15, 2005
Results First Submitted: December 24, 2015
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017