Neuropeptides in Human Reproduction

Purpose

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.

Condition

  • Hypogonadotropic Hypogonadism

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Naloxone, Kisspeptin, GnRH 		Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone
  • Drug: Kisspeptin 112-121
    Subjects will receive up to 10 IV doses of kisspeptin 112-121
    Other names:
    • Metastin 45-54
  • Drug: Naloxone
    Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
  • Drug: GnRH
    Subjects will receive up to 10 doses of IV GnRH
    Other names:
    • Gonadotropin-releasing hormone

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Study Coordinator
617-643-2308
MGHKisspeptinResearch@partners.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Study Coordinator
617-643-2308
MGHKisspeptinResearch@partners.org