Kisspeptin Administration Subcutaneously to Patients With IHH

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896293
• Other study ID #: FD007843
• Status: Recruiting
• Phase: Phase 2
• Start date: February 3, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• 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 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.

Funding Source: FDA OOPD

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism

Intervention

Drug:
• kisspeptin 112-121
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 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	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)	2 weeks
Secondary	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.	2 weeks