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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.