Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Launched by STEPHANIE B. SEMINARA, MD · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a hormone called kisspeptin to see if it can help women with certain reproductive disorders, specifically hypothalamic amenorrhea (HA) and hypogonadotropic hypogonadism. These conditions can cause irregular or absent menstrual cycles because of low hormone levels. The researchers want to find out if giving kisspeptin can trigger the release of other reproductive hormones and help women release eggs from their ovaries. Participants will receive kisspeptin through a small injection under the skin for two weeks, and the study will involve monitoring their ovaries with ultrasounds and taking frequent blood samples to see how their bodies respond.

To be eligible for this study, women must have a confirmed diagnosis of hypothalamic amenorrhea and meet certain health criteria, such as having normal blood pressure and not currently using hormonal treatments. Participants should not be pregnant or breastfeeding, and they should not have conditions that could interfere with the study. This trial is currently recruiting women aged between 18 and 40. If you choose to participate, you can expect close monitoring and support throughout the trial, as researchers gather valuable information to better understand how kisspeptin affects reproductive health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea)
• • • Confirmed diagnosis by medical provider supported by low sex steroids in the setting 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 range for normal women
• • Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration)
• • Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration
• • 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
• 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) and/or active use of illicit drugs
• • • Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. Individuals who regularly use marijuana may be asked to washout as referenced in the medication washout section below
• • Pregnant or trying to become pregnant
• • Breast feeding
• • History of bilateral oophorectomy (ovaries were removed)