Neuropeptides in Human Reproduction

Phase 1

Completed

• Conditions: Hypogonadotropic Hypogonadism
• Interventions: Drug: Kisspeptin 112-121; Drug: Naloxone; Drug: GnRH

• Registration Number: NCT01952782
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-30
• Study Start: 2014-04-30
• Primary Completion: 2016-05-31
• Study Completion: 2016-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Naloxone, Kisspeptin, GnRH	Kisspeptin 112-121	Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone
Naloxone, Kisspeptin, GnRH	Naloxone	Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone
Naloxone, Kisspeptin, GnRH	GnRH	Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone

Primary Outcome Measures

Name	Time	Method
Average difference in luteinizing hormone (LH) concentration before and after kisspeptin	Within 30 minutes of administration	Compares response to kisspeptin on and off naloxone infusion

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States