CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
r-metHuLeptin +2 moredrug
Likely dose
r-metHuLeptin 0.08 mg/kg once daily via subcutaneous injectionAI-extracted
Key inclusion· 5
  • ✓Hypothalamic amenorrhea of at least 6 months duration with low or normal LH and FSH, due to strenuous exercise (>20 miles/week) or low weight
  • ✓Secondary or primary hypothalamic amenorrhea with some pubertal development and normal screening labs
  • ✓Age 18–35 years
  • ✓Body weight within ±15% of ideal body weight and stable for 6 months (change <5 lbs)
Key exclusion· 13
  • ✕Significant medical history affecting hormone concentrations or study participation
  • ✕Renal or hepatic disease: creatinine >1.4, AST/ALT >2× upper limit of normal
  • ✕Diagnosed diabetes mellitus, myocardial ischemia, or malignancy (except basal cell carcinoma or cervical carcinoma in situ)
  • ✕Active eating disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00130117
NCT00130117Phase 2Completed
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Randomized, Double-blind, Placebo-controlled Trial of Human Recombinant Leptin (r-metHuLeptin) for the Treatment of Hypothalamic (Exercise-Induced) Amenorrhea

Beth Israel Deaconess Medical Center·interventional·Posted Aug 15, 2005·Updated May 17, 2017

In Brief

A Phase 2 clinical trial evaluating r-metHuLeptin, Oral Contraceptive Pills (OCPs), and 1 other intervention for Amenorrhea. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function, and overall sense of well-being in women with hypothalamic (exercise-induced) amenorrhea (HA) who are being treated with oral contraceptive pills (OCPs), compared to placebo. Women with hypothalamic amenorrhea have low leptin levels. This study is based on the hypothesis that the relative leptin deficiency in women with hypothalamic (exercise-induced) amenorrhea may be the reason for the lack of menstrual cycles, hormone abnormalities, and bone loss associated with this condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmenorrhea
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR), Amgen

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2005
Enrollment StartApr 1, 2010
Primary CompletionAug 1, 2011
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.9 years ago

Interventions

r-metHuLeptindrug

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

Oral Contraceptive Pills (OCPs)drug

Sprintec taken orally once daily.

Placeboother

placebo (no active medication)