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Completed

NCT Number: NCT01952782

Neuropeptides in Human Reproduction

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.

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Key information

Conditions

Hypogonadotropic Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • For healthy men and healthy regularly cycling women: normal
  • 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

Treatment and study plan

Kisspeptin 112-121

Drug

Subjects will receive up to 10 IV doses of kisspeptin 112-121

Other names: Metastin 45-54

naloxone

Drug

Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.

GnRH

Drug

Subjects will receive up to 10 doses of IV GnRH

Other names: Gonadotropin-releasing hormone

Primary outcomes

  1. Average difference in luteinizing hormone (LH) concentration before and after kisspeptin

    Time frame: Within 30 minutes of administration

    Compares response to kisspeptin on and off naloxone infusion

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2013
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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