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Neuropeptides in Human Reproduction

Primary Purpose

Hypogonadotropic Hypogonadism

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Kisspeptin 112-121

Naloxone

GnRH

About this trial

This is an interventional other trial for Hypogonadotropic Hypogonadism focused on measuring Reproductive disorders, Hypogonadotropic hypogonadism, Kisspeptin, GnRH, Naloxone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Naloxone, Kisspeptin, GnRH

Arm Description

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

Outcomes

Primary Outcome Measures

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

Compares response to kisspeptin on and off naloxone infusion

Secondary Outcome Measures

Full Information

NCT ID

NCT01952782

First Posted

September 24, 2013

Last Updated

July 17, 2023

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01952782

Brief Title

Neuropeptides in Human Reproduction

Official Title

Neuropeptides in Human Reproduction

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2014 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadotropic Hypogonadism

Keywords

Reproductive disorders, Hypogonadotropic hypogonadism, Kisspeptin, GnRH, Naloxone

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Naloxone, Kisspeptin, GnRH

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Kisspeptin 112-121

Other Intervention Name(s)

Metastin 45-54

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Naloxone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

GnRH

Other Intervention Name(s)

Gonadotropin-releasing hormone

Intervention Description

Subjects will receive up to 10 doses of IV GnRH

Primary Outcome Measure Information:

Title

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

Description

Compares response to kisspeptin on and off naloxone infusion

Time Frame

Within 30 minutes of administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Coordinator

Phone

617-643-2308

MGHKisspeptinResearch@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie B Seminara, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

617-643-2308

MGHKisspeptinResearch@partners.org

First Name & Middle Initial & Last Name & Degree

Stephanie B Seminara, MD

First Name & Middle Initial & Last Name & Degree

Yee-Ming Chan, MD, PhD

First Name & Middle Initial & Last Name & Degree

Margaret Lippincott, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31132118

Citation

Lippincott 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.

Results Reference

derived

PubMed Identifier

29669934

Citation

Chan 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.

Results Reference

derived

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Neuropeptides in Human Reproduction

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