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Neuropeptides in Human Reproduction

Neuropeptides in Human Reproduction

Non Recruiting
18-75 years
All
Phase 1

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Overview

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.

Eligibility

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 details
    Hypogonadotropic Hypogonadism

NCT01952782

Massachusetts General Hospital

20 August 2025

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