Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

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.

CT.gov Identifier
NCT07224438
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Stephanie B. Seminara, MD
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Hypogonadotropic hypogonadism 3 with or without anosmia
Study Drug
Kisspeptin 112-121
Genes
PROKR2
Study Dates
Dec 2025 - May 2030
Sex
Female
Age
18 - 45 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • * Female
  • * Ages 18-45 years
  • * Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism)
  • * Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
  • * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
  • * Negative serum hCG pregnancy test
  • * No current or recent use of a medication (including hormonal replacement) 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 its method of administration
  • * If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug
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)
  • * Active use of illicit drugs
  • * Pregnant
  • * Trying to become pregnant during protocol participation
  • * Breast feeding
  • * History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

Protocol 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.

Study Locations

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