Phase
Condition
Hormone Deficiencies
Amenorrhea
Hypogonadism
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)
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.
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
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.