Pulsatile subcutaneous kisspeptin to trigger ovulation in women with hypothalamic amenorrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase 2 study delivering kisspeptin 112-121 by a subcutaneous pump in a pulsatile fashion for two weeks to women with functional hypothalamic amenorrhea. Participants will have baseline screening including history, exam, labs, and a pelvic ultrasound, then receive continuous pulsatile dosing while undergoing repeated pelvic ultrasounds and frequent blood sampling to measure hormone responses. Blood samples will be taken every 10 minutes during several two-hour sessions (with optional extended sampling up to 10 hours before and after treatment), and ovarian follicle growth will be monitored with approximately four ultrasound visits. The protocol is designed to measure whether physiological patterns of gonadotropin release and follicular development can be restored by pulsatile kisspeptin delivery.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Study Coordinator
• Email: MGHKisspeptinResearch@partners.org
• Phone: 617-643-2308

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.