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Kisspeptin Administration Subcutaneously to Patients With IHH

Primary Purpose

Hypogonadotropic Hypogonadism

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
kisspeptin 112-121
GnRH
Sponsored by
Stephanie B. Seminara, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypogonadotropic Hypogonadism focused on measuring Hypogonadotropic Hypogonadism, Kisspeptin, Idiopathic Hypogonadotropic Hypogonadism, GnRH

Eligibility Criteria

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

Inclusion Criteria: Congenital IHH o Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg) Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration Exclusion Criteria: Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol History of a medication reaction requiring emergency medical care Excessive alcohol consumption (>10 drinks/week) and/or active use of illicit drugs o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. Individuals who regularly use marijuana may be asked to washout as referenced in the medication washout section below. Pregnant or trying to become pregnant Breast feeding History of bilateral oophorectomy (ovaries were removed)

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

kisspeptin pump

Arm Description

SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)

Outcomes

Primary Outcome Measures

Average change in luteinizing hormone (LH) pulse amplitude
Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)

Secondary Outcome Measures

Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation
Percentage of female participants that develop a mature follicle or ovulate. Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.

Full Information

First Posted
May 31, 2023
Last Updated
July 20, 2023
Sponsor
Stephanie B. Seminara, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05896293
Brief Title
Kisspeptin Administration Subcutaneously to Patients With IHH
Official Title
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Gonadotropin-releasing hormone (GnRH) may be administered subcutaneously (SC) for approximately six days in a pulsatile fashion, in order to prime the pituitary gland. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.
Detailed Description
Assignment: All study subjects will undergo the same interventions. Delivery of Interventions: Each subject will undergo a review of their medical history, physical exam, and screening laboratories. A pelvic ultrasound will be performed on women to assess baseline follicular size. A pump may be placed to administer pulsatile SC GnRH for approximately six days. A pump will be placed to administer pulsatile SC kisspeptin for two weeks. During the course of kisspeptin administration, subjects will Undergo q10 min blood sampling (approximately 10 sessions, 70 minutes each) For women, undergo pelvic ultrasounds (approximately 3 sessions) Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

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, Idiopathic Hypogonadotropic Hypogonadism, GnRH

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kisspeptin pump
Arm Type
Experimental
Arm Description
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
Intervention Type
Drug
Intervention Name(s)
kisspeptin 112-121
Other Intervention Name(s)
metastin 45-54
Intervention Description
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
Intervention Type
Drug
Intervention Name(s)
GnRH
Other Intervention Name(s)
gonadotropin-releasing hormone
Intervention Description
SC administration of GnRH for approximately six days (pulsatile, every 120 minutes)
Primary Outcome Measure Information:
Title
Average change in luteinizing hormone (LH) pulse amplitude
Description
Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation
Description
Percentage of female participants that develop a mature follicle or ovulate. Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Congenital IHH o Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg) Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration Exclusion Criteria: Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol History of a medication reaction requiring emergency medical care Excessive alcohol consumption (>10 drinks/week) and/or active use of illicit drugs o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. Individuals who regularly use marijuana may be asked to washout as referenced in the medication washout section below. Pregnant or trying to become pregnant Breast feeding History of bilateral oophorectomy (ovaries were removed)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
617-724-8592
Email
MGHKisspeptinResearch@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie 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
617-724-8592
Email
MGHKisspeptinResearch@partners.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Kisspeptin Administration Subcutaneously to Patients With IHH

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