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Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders (KASPR)

Primary Purpose

Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism

Status
Recruiting
Phase
Phase 1
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 Hypothalamic Amenorrhea focused on measuring Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism, Kisspeptin, GnRH

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea) • 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) Laboratory Studies: Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration) 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 • 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 90 minutes)

Outcomes

Primary Outcome Measures

The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
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.

Secondary Outcome Measures

Change of luteinizing hormone (LH) pulse amplitude
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration

Full Information

First Posted
November 21, 2022
Last Updated
July 17, 2023
Sponsor
Stephanie B. Seminara, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05633966
Brief Title
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Acronym
KASPR
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
December 16, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (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 women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) 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: The subject will undergo a review of their medical history, physical exam, and screening laboratories. A pelvic ultrasound will be performed to assess baseline follicular size. A pump may be placed to administer pulsatile SC gonadotropin-releasing hormone (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 4 sessions, 2 hours each) Undergo pelvic ultrasounds (approximately 4 sessions) Optional q10 min sampling up to 10 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
Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism
Keywords
Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism, Kisspeptin, GnRH

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kisspeptin pump
Arm Type
Experimental
Arm Description
SC administration of kisspeptin for two weeks (pulsatile, every 90 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 90 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
The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
Description
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
Secondary Outcome Measure Information:
Title
Change of luteinizing hormone (LH) pulse amplitude
Description
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea) • 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) Laboratory Studies: Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration) 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 • 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

Learn more about this trial

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

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