Kisspeptin Administration Subcutaneously to Patients With IHH

Stephanie B. Seminara, MD

Status and phase

Enrolling

Phase 2

Conditions

Hypogonadotropic Hypogonadism

Treatments

Drug: kisspeptin 112-121

Drug: leuprolide acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT05896293

FD007843

Details and patient eligibility

About

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

Full 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

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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
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)