Opioid Antagonism 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 evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with idiopathic hypogonadotropic hypogonadism (HH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephanie B. Seminara, MD
• Treatments: Naloxone; Prolactin Release-Inhibiting Factors

Criteria

• 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 opiate drug use

• No excessive alcohol consumption (<10 drinks/week)

• Not currently seeking fertility

• If applicable, able to undergo appropriate washout from hormone therapy

• 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

• 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; off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women

• Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated

• Negative urine drug screening panel

• 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