Study of Leptin for the Treatment of Hypothalamic Amenorrhea

Completed · Phase 2 · Has a placebo group

Conditions studied: Amenorrhea

In brief

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.

Key facts

Study ID

NCT00130117

Run by

Beth Israel Deaconess Medical Center

People needed

20

Starts

2010-04-01

Expected to finish

2016-12-01

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• 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 history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebral vascular or coronary artery disease
• Known or suspected carcinoma of the breast
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Hepatic adenomas or carcinomas
• Cholestatic jaundice of pregnancy or jaundice with prior OCP use
• Other endocrine causes of amenorrhea, e.g.
• hyperprolactinemia
• hypothyroidism or hyperthyroidism
• Cushing's syndrome
• congenital adrenal hyperplasia (elevated 17 OH progesterone)

Where it is running

• Beth Israel Deaconess Medical Center General Clinical Research Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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