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Kisspeptin for Hypothalamic Amenorrhea

This study is looking at whether a natural hormone called kisspeptin 112-121 can help women with hypothalamic amenorrhea (HA) produce reproductive hormones and release eggs. HA is a condition where your brain doesn't send the right signals to your ovaries, leading to missed periods. Researchers will give kisspeptin 112-121 as shots under the skin (subcutaneously) for two weeks. They will measure changes in a hormone called luteinizing hormone (LH) to see if the treatment is working. You might be able to join if you are a woman between 18 and 45 years old with HA, have normal blood pressure, and meet other health criteria. The study aims to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study where all 20 participants will receive the same treatment, kisspeptin 112-121. The phase of the study is not specified.
What's involved
You will have a medical history review, physical exam, and blood tests. You will also have pelvic ultrasounds and receive kisspeptin 112-121 shots for two weeks. During this time, you will have frequent blood draws (about 4 sessions, 2 hours each) and more ultrasounds (about 4 sessions).
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, change in luteinizing hormone (LH) pulse amplitude, is measured at 2 weeks.

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NCT07224438

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

Recruiting
PHASE2Ages 18–45InterventionalTreatment
Stephanie B. Seminara, MD
~20 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:kisspeptin 112-121

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of luteinizing hormone (LH) pulse amplitude
Measured over 2 weeks

Conditions

Hypothalamic Amenorrhea
Hypogonadotropic Hypogonadism

Explore related trials

Hypogonadotropic HypogonadismHypothalamic amenorrhea

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Study Coordinator
[email protected]
617-643-2308
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change of luteinizing hormone (LH) pulse amplitude2 weeks

    Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration