Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Last updated: July 30, 2024
Sponsor: Stephanie B. Seminara, MD
Overall Status: Active - Recruiting

Phase

1

Condition

Hypogonadism

Hormone Deficiencies

Amenorrhea

Treatment

GnRH

Kisspeptin 112-121

Clinical Study ID

NCT05633966
2022P001039
  • Ages 18-45
  • Female

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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functionalhypothalamic amenorrhea)

• 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)

  • Laboratory Studies:

  • Hemoglobin no less than 0.5 g/dL below the lower limit of the reference rangefor normal women

  • Negative serum hCG pregnancy test at screening (additional urine pregnancy testwill be conducted prior to drug administration)

  • Not using hormonal replacement or willing to complete an appropriate washout forthat particular medication and method of administration

  • 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

• Any active use of marijuana will be evaluated by a study medical professional todetermine if it may impact study participation. Individuals who regularly usemarijuana may be asked to washout as referenced in the medication washout sectionbelow

  • Pregnant or trying to become pregnant

  • Breast feeding

  • History of bilateral oophorectomy (ovaries were removed)

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: GnRH
Phase: 1
Study Start date:
December 16, 2022
Estimated Completion Date:
December 31, 2025

Study 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 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

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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