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Trial · Interventional

CompletedPhase 1Registry data

Neuropeptides in Human Reproduction

NCTNCT01952782 (opens ClinicalTrials.gov in a new tab)Other id2013P001543
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Overview

Status
Completed
Phase
Phase 1
Enrollment
61 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
30 Apr 2014
Primary completion
31 May 2016
Completion
31 May 2016
First posted
30 Sept 2013 (estimated)
Last update posted
31 Jul 2024
Conditions
Hypogonadotropic Hypogonadism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 1

    Neuropeptides in Human Reproduction

    NCT01952782

    30 Apr 2014 to 31 May 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Kisspeptin 112-121Drug
  • NaloxoneDrug
  • GnRHDrug

Arms1

  • Experimental

    Naloxone, Kisspeptin, GnRH

    Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Within 30 minutes of administration

    Registry description

    Compares response to kisspeptin on and off naloxone infusion

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLippincott MF, Leon S, Chan YM, Fergani C, Talbi R, Farooqi IS, Jones CM, Arlt W, Stewart SE, Cole TR, Terasawa E, Hall JE, Shaw ND, Navarro VM, Seminara SB. Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4304-4318. doi: 10.1210/jc.2019-00146. PMID 31132118
  • DerivedChan YM, Lippincott MF, Kusa TO, Seminara SB. Divergent responses to kisspeptin in children with delayed puberty. JCI Insight. 2018 Apr 19;3(8):e99109. doi: 10.1172/jci.insight.99109. eCollection 2018 Apr 19. PMID 29669934

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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