Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
Purpose
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.
Condition
- Hypogonadotropic Hypogonadism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental: kisspeptin, GnRH |
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Stephanie B. Seminara, MD
Detailed Description
- Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure. - Delivery of Interventions: - Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit. - On the day of the inpatient study, the subjects will - Undergo q10 min blood sampling for 6 hours, - Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total), - Undergo q10 min blood samplings for another 6 hours, - Receive a single GnRH IV bolus at hour 51.