Phase
Condition
Hypogonadism
Hormone Deficiencies
Amenorrhea
Treatment
GnRH
Kisspeptin 112-121
Clinical Study ID
Ages 18-45 Female
Study Summary
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
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
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