RECRUITING

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Conditions

Hypogonadotropic Hypogonadism hypogonadotropic hypogonadism, kisspeptin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Quick Facts

Study Start:2021-01-20

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04648969

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

617-726-5384

MGHKisspeptinResearch@partners.org

Principal Investigator

Stephanie Seminara

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Stephanie B. Seminara, MD

Stephanie Seminara, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-20

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2021-01-20

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

hypogonadotropic hypogonadism, kisspeptin

Additional Relevant MeSH Terms

Hypogonadotropic Hypogonadism