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Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Primary Purpose

Hypogonadotropic Hypogonadism

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

kisspeptin 112-121

GnRH

About this trial

This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring hypogonadotropic hypogonadism, kisspeptin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion/exclusion criteria:

Age 18 years and older,
Confirmed diagnosis of HH with
- Low testosterone or estradiol,
- Low or low-normal gonadotropin levels,
- Thyroid stimulating hormone (TSH) and prolactin within the reference range,
- Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI),
All other medical conditions stable and well controlled,
No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,
No history of a medication reaction requiring emergency medical care,
No illicit drug use,
No excessive alcohol consumption (<10 drinks/week),
Normal blood pressure (BP), (systolic BP < 140 mm Hg, diastolic < 90 mm Hg),
White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,
Prolactin below 110% of the upper limit of the reference range,
Hemoglobin
- Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,
- Men: on adequate testosterone replacement therapy: normal male reference range,
Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated,
For women,
- Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration),
- Not breastfeeding and not pregnant.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: kisspeptin, GnRH

Arm Description

• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.

Outcomes

Primary Outcome Measures

Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin

Change in LH amplitude before, during and after kisspeptin administration

Secondary Outcome Measures

Average change in LH pulse frequency in response to kisspeptin

Change in LH frequency before and after kisspeptin administration

Full Information

NCT ID

NCT04648969

First Posted

November 11, 2020

Last Updated

July 20, 2023

Sponsor

Stephanie B. Seminara, MD

1. Study Identification

Unique Protocol Identification Number

NCT04648969

Brief Title

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Official Title

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2021 (Actual)

Primary Completion Date

May 31, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stephanie B. Seminara, MD

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 goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.

Detailed Description

Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure. Delivery of Interventions: Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit. On the day of the inpatient study, the subjects will Undergo q10 min blood sampling for 6 hours, Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total), Undergo q10 min blood samplings for another 6 hours, Receive a single GnRH IV bolus at hour 51.

6. Conditions and Keywords

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

Hypogonadotropic Hypogonadism

Keywords

hypogonadotropic hypogonadism, kisspeptin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: kisspeptin, GnRH

Arm Type

Experimental

Arm Description

• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.

Intervention Type

Drug

Intervention Name(s)

kisspeptin 112-121

Other Intervention Name(s)

metastin 45-54

Intervention Description

20 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets)

Intervention Type

Drug

Intervention Name(s)

GnRH

Other Intervention Name(s)

gonadotropin-releasing hormone

Intervention Description

1 intravenous dose of GnRH

Primary Outcome Measure Information:

Title

Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin

Description

Change in LH amplitude before, during and after kisspeptin administration

Time Frame

52 hours

Secondary Outcome Measure Information:

Title

Average change in LH pulse frequency in response to kisspeptin

Description

Change in LH frequency before and after kisspeptin administration

Time Frame

52 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion/exclusion criteria: Age 18 years and older, Confirmed diagnosis of HH with Low testosterone or estradiol, Low or low-normal gonadotropin levels, Thyroid stimulating hormone (TSH) and prolactin within the reference range, Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI), All other medical conditions stable and well controlled, No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition, No history of a medication reaction requiring emergency medical care, No illicit drug use, No excessive alcohol consumption (<10 drinks/week), Normal blood pressure (BP), (systolic BP < 140 mm Hg, diastolic < 90 mm Hg), White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range, Prolactin below 110% of the upper limit of the reference range, Hemoglobin Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women, Men: on adequate testosterone replacement therapy: normal male reference range, Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated, For women, Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration), Not breastfeeding and not pregnant.

Central Contact Person:

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

Study Coordinator

Phone

617-726-5384

MGHKisspeptinResearch@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie Seminara

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

617-726-5384

MGHKisspeptinResearch@partners.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

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