Kisspeptin Administration Subcutaneously to Patients With IHH

Launched by STEPHANIE B. SEMINARA, MD · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a hormone called kisspeptin to see if it can help people with a condition known as idiopathic hypogonadotropic hypogonadism (IHH). This condition means that the body doesn't produce enough sex hormones, which can affect reproductive health. The researchers want to find out if giving kisspeptin through an injection can stimulate the release of other important hormones in both men and women. For women, the trial will also check if kisspeptin can help with egg release from the ovaries. Participants will receive kisspeptin for two weeks while the researchers monitor how their bodies respond through blood tests and ultrasound exams.

To be eligible for this trial, participants should be diagnosed with congenital IHH and have low levels of sex hormones. They should also have normal blood pressure and not be using certain hormonal medications. There are some exclusions, such as being pregnant or having a history of ovary removal. For those who qualify, the study will involve regular monitoring and injections, providing a chance to help improve understanding of reproductive health in individuals with IHH.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Congenital IHH
• • o 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)
• • 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
• • o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation.
• • Pregnant or trying to become pregnant
• • Breast feeding
• • History of bilateral oophorectomy (ovaries were removed)