Status:
COMPLETED
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Conditions:
Amenorrhea
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief 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, hor...
Detailed Description
Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to regulate energy usage and hormone levels. Women with HA who do not have regular periods have low leptin level...
Eligibility Criteria
Inclusion
- 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 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)
- polycystic ovarian syndrome (elevated androgens or LH/FSH ratio \>1.5)
- primary ovarian failure (elevated FSH)
- On medications known to affect the hormones to be measured such as
- glucocorticoids
- anti seizure medications
- thyroid hormones
- estrogen (must be off at least 3 months prior to participating in the study)
- A known history of anaphylaxis or anaphylactoid-like reactions, or a known hypersensitivity to E. Coli derived proteins
- Breast feeding, pregnant, or wanting to become pregnant during the next 6 months.
- We will screen for these conditions through a detailed history and systems review, physical examination, laboratory evaluation (as described above in Screening Methods), and EKG.
- In the Reward Sub-study subjects will be asked to fill out a standard BIDMC MRI safety screening form prior to entering the magnet.
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00130117
Start Date
April 1 2010
End Date
December 1 2016
Last Update
May 17 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center General Clinical Research Center
Boston, Massachusetts, United States, 02215