Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Hypogonadotropic Hypogonadism Clinical Trial

— KASPR  

Official title:

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633966
• Other study ID #: 2022P001039
• Status: Recruiting
• Phase: Phase 1
• Start date: December 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: Study Coordinator
• Phone: 617-724-8592
• Email: MGHKisspeptinResearch[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amenorrhea
• Hypogonadism
• Hypogonadotropic Hypogonadism
• Hypothalamic Amenorrhea

Intervention

Drug:
• Kisspeptin 112-121
SC administration of kisspeptin for two weeks (pulsatile, every 90 minutes)
• GnRH
SC administration of GnRH for approximately six days (pulsatile, every 120 minutes)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie B. Seminara, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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	2 weeks