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Study of Leptin for the Treatment of Hypothalamic Amenorrhea

NCT00130117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-17

Study results available
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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.

Conditions

  • Amenorrhea

Interventions

DRUG

r-metHuLeptin

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

DRUG

Oral Contraceptive Pills (OCPs)

Sprintec taken orally once daily.

OTHER

Placebo

placebo (no active medication)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Amgen

    collaborator INDUSTRY

  • Beth Israel Deaconess Medical Center

    lead OTHER

Principal Investigators

  • Christos S Mantzoros, MD, ScD · Beth Israel Deaconess Medical Center, Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-08-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00130117 on ClinicalTrials.gov