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Completed
NCT04648969
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
Conditions: Hypogonadotropic Hypogonadism
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 18
Sponsor: Stephanie B. Seminara, MD
Location: Massachusetts General Hospital Boston Massachusetts
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.
Eligibility Criteria
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 (\
Source: ClinicalTrials.gov (NCT04648969). StuddyBuddy aggregates publicly available trial information.