RECRUITING

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

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Conditions

Hypothalamic AmenorrheaHypogonadotropic HypogonadismKisspeptin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Quick Facts

Study Start:2022-12-16
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05633966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea)
  2. * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
  3. * Laboratory Studies:
  4. * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
  5. * Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration)
  6. * Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration
  7. * No current or recent use of a medication 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 method of administration
  1. * Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
  2. * Excessive alcohol consumption (\>10 drinks/week) and/or active use of illicit drugs
  3. * Pregnant or trying to become pregnant
  4. * Breast feeding
  5. * History of bilateral oophorectomy (ovaries were removed)

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
617-726-1895
MGHKisspeptinResearch@partners.org

Principal Investigator

Stephanie Seminara, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Stephanie B. Seminara, MD

  • Stephanie Seminara, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-16
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-12-16
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Hypothalamic Amenorrhea
  • Hypogonadotropic Hypogonadism
  • Kisspeptin

Additional Relevant MeSH Terms

  • Hypothalamic Amenorrhea
  • Hypogonadotropic Hypogonadism