Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Launched by STEPHANIE B. SEMINARA, MD · Nov 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for a condition called hypogonadotropic hypogonadism (HH), which is when the body doesn't produce enough hormones that are essential for sexual development and function. The researchers are testing the use of a substance called kisspeptin, which may help stimulate hormone production in people with this condition. The trial is currently looking for participants aged 18 and older, who have been diagnosed with HH and meet specific health criteria, such as having low hormone levels but stable overall health.

If you or someone you know is considering joining this trial, participants can expect to receive kisspeptin over an extended period. The researchers will monitor your health closely throughout the study. To be eligible, participants should not be on certain medications that affect hormone levels, should not have serious health issues, and women must not be pregnant or breastfeeding. This trial aims to develop better treatments for HH, and your participation could contribute to important advancements in care.

Gender

ALL

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 (\<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 pregnancy test will be conducted prior to drug administration),
• • Not breastfeeding and not pregnant.