Study of Leptin for the Treatment of Hypothalamic Amenorrhea (NCT00130117) | Clinical Trial Compass
CompletedPhase 2
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
United States20 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for HA subjects
* Hypothalamic amenorrhea of at least 6 months duration with low or normal LH and FSH, e.g. due to strenuous exercise (running \>20 miles per week or equivalent) or low weight
* Can be secondary HA OR primary HA with some pubertal development and normal screening labs
* Age 18-35 years old
* Body weight within +/- 15% of ideal body weight and stable for 6 months (no change \> 5 lbs)
* Baseline leptin \<5 ng/mL (except for the Cognitive Sub-Study Baseline visit where baseline leptin will be greater than 5ng/mL)
Inclusion criteria for eumenorrheic controls for Reward Sub-study
* Normal menstrual cycles (between 25 and 35 days)
* Age 18-35
* Body weight within +/- 15% of ideal body weight and stable 6 months (no change \> 5 lbs)
* Baseline leptin \>5 ng/mL
Exclusion criteria:
* We will exclude subjects with:
* Significant medical history that may affect the concentrations of the hormones to studied or ability to participate in the study
* renal or hepatic disease (creatinine \> 1.4, AST/ALT \> 2x upper limit of normal)
* diagnosed diabetes mellitus
* myocardial ischemia
* malignancy (other than basal cell carcinoma of the skin or in situ carcinoma of the cervix)
* malabsorption
* alcoholism, drug abuse, or smoking
* active eating disorder
* depression or other psychiatric disease
* anemia (Hb10 gm/dL on 2 occasions)
* Conditions that are contraindicated for oral contraceptive use:
* Thrombophlebitis or thromboembolic disorders
* A past his…
What they're measuring
1
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