Trial Outcomes & Findings for Study of Leptin for the Treatment of Hypothalamic Amenorrhea (NCT NCT00130117)
NCT ID: NCT00130117
Last Updated: 2017-05-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
36 weeks
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
Baseline characteristics by cohort
| Measure |
r-metHuLeptin
n=11 Participants
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
n=9 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
26.6 years
STANDARD_DEVIATION 1.4 • n=99 Participants
|
25.4 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
26 years
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
9 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 36 weeksOutcome measures
| Measure |
r-metHuLeptin
n=7 Participants
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
n=6 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
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
|
51.0 g
Interval 43.4 to 58.2
|
58.2 g
Interval 55.2 to 61.4
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: 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
Outcome measures
| Measure |
r-metHuLeptin
n=4 Participants
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)
|
|---|---|---|
|
Bone Markers - Ctx and Sclerostin
CTX
|
0.60 ng/mL
Interval 0.39 to 0.83
|
—
|
|
Bone Markers - Ctx and Sclerostin
Sclerostin
|
0.08 ng/mL
Interval 0.07 to 0.09
|
—
|
SECONDARY outcome
Timeframe: 36 weeksOutcome measures
| Measure |
r-metHuLeptin
n=7 Participants
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
n=6 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Body Composition BMI
|
20.8 BMI-kg/m^2
Standard Error 0.6
|
21.1 BMI-kg/m^2
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 36 weeksOutcome measures
| Measure |
r-metHuLeptin
n=7 Participants
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
n=6 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Total Body BMD
|
1.07 g/cm^2
Interval 1.05 to 1.16
|
1.13 g/cm^2
Interval 1.09 to 1.23
|
SECONDARY outcome
Timeframe: 36 weeksOutcome measures
| Measure |
r-metHuLeptin
n=7 Participants
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
n=6 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Body Fat
|
23.9 fat %
Standard Error 1.4
|
20.8 fat %
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
r-metHuLeptin
n=10 Participants
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
n=9 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Total Body BMD
|
1.09 g/cm2
Interval 1.06 to 1.15
|
1.13 g/cm2
Interval 1.1 to 1.23
|
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
r-metHuLeptin
n=10 Participants
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
n=9 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Lumbar BMD
|
0.92 g/cm2
Interval 0.8 to 1.03
|
0.97 g/cm2
Interval 0.9 to 1.01
|
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
r-metHuLeptin
n=10 Participants
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
n=9 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Radial BMD
|
0.54 g/cm2
Interval 0.52 to 0.6
|
0.54 g/cm2
Interval 0.53 to 0.56
|
SECONDARY outcome
Timeframe: 9monthsOutcome measures
| Measure |
r-metHuLeptin
n=10 Participants
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
n=9 Participants
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Hip BMD
|
0.89 g/cm2
Interval 0.8 to 1.03
|
0.88 g/cm2
Interval 0.8 to 1.02
|
Adverse Events
r-metHuLeptin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
r-metHuLeptin
n=11 participants at risk
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
n=6 participants at risk
placebo
Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.
Placebo: placebo (no active medication)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
local injection site reactions with erythematous rashes
|
18.2%
2/11 • Number of events 2
11 participants started on the metreleptin arm , although only 7 finished the study. hence participants at risk are 11
|
0.00%
0/6
11 participants started on the metreleptin arm , although only 7 finished the study. hence participants at risk are 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place