Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Description

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.

Conditions

Hypogonadotropic Hypogonadism

Study Overview

Study Details

Study overview

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.

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Condition
Hypogonadotropic Hypogonadism
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stephanie B. Seminara, MD,

Stephanie Seminara, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-05-31