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 range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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