Clinical trial NCT05896293: Kisspeptin Administration Subcutaneously to Patients With IHH
Official title: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypogonadotropic Hypogonadism
Keywords: Hypogonadotropic Hypogonadism
Kisspeptin
Idiopathic Hypogonadotropic Hypogonadism
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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. 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

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 single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration.
* A pelvic ultrasound will be performed on women to assess baseline follicular size.
* 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

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
* 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.
* Pregnant or trying to become pregnant
* Breast feeding
* History of bilateral oophorectomy (ovaries were removed)

Primary outcomes:
measure: Average change in luteinizing hormone (LH) pulse amplitude
timeFrame: 2 weeks
Secondary outcomes:
measure: Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stephanie Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References: