Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: kisspeptin 112-121.
- Who it may be relevant to
- Registry conditions: Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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
Interventions
- Drug kisspeptin 112-121
SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)
Primary outcome measures
- Change of luteinizing hormone (LH) pulse amplitude [Time frame: 2 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07224438 · 565178 · R37HD043341