Kisspeptin Administration Subcutaneously to Patients With IHH

Last updated: September 30, 2025
Sponsor: Stephanie B. Seminara, MD
Overall Status: Active - Recruiting

Phase

2

Condition

Hormone Deficiencies

Hypogonadism

Treatment

GnRH

leuprolide acetate

kisspeptin 112-121

Clinical Study ID

NCT05896293
FD007843
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Congenital IHH o Confirmed diagnosis by medical provider supported by low sex steroids in thesetting of low or inappropriately normal gonadotropins

  • Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)

  • No current or recent use of a medication that, in the opinion of a studyinvestigator, can modulate the reproductive axis or willing to complete anappropriate washout for that particular medication and method of administration

Exclusion

Exclusion Criteria:

  • Any condition (medical, mental, or behavioral) that, in the opinion of a studyinvestigator, would likely interfere with participation in/completion of theprotocol

  • 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 todetermine if it may impact study participation.

  • Pregnant or trying to become pregnant

  • Breast feeding

  • History of: bilateral oophorectomy (both ovaries were removed), breast cancer,thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, orundiagnosed abnormal genital bleeding

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: GnRH
Phase: 2
Study Start date:
February 03, 2023
Estimated Completion Date:
May 31, 2028

Study 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. (Previously administration of Gonadotropin Releasing Hormone (GnRH) was used in this study.)

  • 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 4 sessions)

  • Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

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