Overview

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Status:
Recruiting
Trial end date:
2025-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stephanie B. Seminara, MD
Treatments:
Hormones
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.