Using kisspeptin to treat hypogonadotropic hypogonadism

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

This study is testing if giving kisspeptin can help people with hypogonadotropic hypogonadism improve their hormone levels.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04648969 on ClinicalTrials.gov

What this trial studies

This study aims to explore new treatment options for patients with hypogonadotropic hypogonadism (HH) by administering exogenous kisspeptin. Participants will undergo a thorough medical history review and screening before receiving kisspeptin through intravenous boluses over a specified period. Each participant will serve as their own control, with randomized dosing to assess the effects of kisspeptin on hormone levels. Blood samples will be taken at regular intervals to monitor changes in hormone levels throughout the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of hypogonadotropic hypogonadism and specific hormonal deficiencies.

Not a fit: Patients with abnormal pituitary or hypothalamic findings, or those on medications affecting reproductive endocrine function, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve hormone levels and overall reproductive health in patients with hypogonadotropic hypogonadism.

How similar studies have performed: While the use of kisspeptin in this context is relatively novel, previous studies have shown promise in using kisspeptin for reproductive hormone regulation.

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.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Stephanie Seminara — Massachusetts General Hospital
• Study coordinator: Study Coordinator

Conditions: Hypogonadotropic Hypogonadism, hypogonadotropic hypogonadism, kisspeptin