Hypogonadotropic Hypogonadism
Conditions
Keywords
Reproductive disorders, Hypogonadotropic hypogonadism, Kisspeptin, GnRH, Naloxone
Brief summary
The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone. We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.
Interventions
Subjects will receive up to 10 IV doses of kisspeptin 112-121
DRUGNaloxone
Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
DRUGGnRH
Subjects will receive up to 10 doses of IV GnRH
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH)) * Normal blood pressure (systolic BP \<140 mm Hg, diastolic BP \<90 mm Hg) * White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range * Negative urine drug screen panel * Hemoglobin: 1. For healthy men and healthy regularly cycling women: normal 2. For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women * Blood urea nitrogen (BUN), creatinine, liver function tests not elevated * For healthy subjects: Normal reproductive function and history * For healthy subjects: Body Mass Index (BMI) 18.5-30kg/m2 * For subjects with HH: All medical conditions stable and well controlled
Exclusion criteria
* History of medication reaction requiring emergency medical attention * Illicit drug use * Consumption of more than 10 alcoholic drinks per week * Difficulty with blood draws * Currently seeking fertility, breastfeeding, or pregnant * For healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication) * For subjects with HH: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average difference in luteinizing hormone (LH) concentration before and after kisspeptin | Within 30 minutes of administration | Compares response to kisspeptin on and off naloxone infusion |
Countries
United States
Outcome results
None listed