Neuropeptides in Human Reproduction

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

Neuropeptides in Human Reproduction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01952782
• Other study ID #: 2013P001543
• Status: Recruiting
• Phase: Phase 1
• Start date: April 30, 2014
• Est. completion date: August 2025

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: Study Coordinator
• Phone: 617-643-2308
• Email: MGHKisspeptinResearch[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism

Intervention

Drug:
• Kisspeptin 112-121
Subjects will receive up to 10 IV doses of kisspeptin 112-121
• Naloxone
Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
• GnRH
Subjects will receive up to 10 doses of IV GnRH

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average difference in luteinizing hormone (LH) concentration before and after kisspeptin	Compares response to kisspeptin on and off naloxone infusion	Within 30 minutes of administration