Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
United States18 participantsStarted 2019-05-03
Plain-language summary
The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion/exclusion criteria:
* Age 18 years and older,
* Confirmed diagnosis of HH with
* Low testosterone or estradiol,
* Low or low-normal gonadotropin levels,
* Thyroid stimulating hormone (TSH) and prolactin within the reference range,
* Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI),
* All other medical conditions stable and well controlled,
* No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,
* No history of a medication reaction requiring emergency medical care,
* No illicit drug use,
* No excessive alcohol consumption (\<10 drinks/week),
* Normal blood pressure (BP), (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg),
* White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,
* Prolactin below 110% of the upper limit of the reference range,
* Hemoglobin
* Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,
* Men: on adequate testosterone replacement therapy: normal male reference range,
* Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated,
* For women,
* Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine preg…
What they're measuring
1
Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin