Dampening the Reproductive Axis With Continuous Kisspeptin

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

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called kisspeptin in women with polycystic ovary syndrome (PCOS), a common reproductive disorder that can affect hormone levels and menstrual cycles. The researchers want to understand how kisspeptin influences the secretion of a hormone called luteinizing hormone (LH), which plays a role in ovulation and fertility. The goal is to gather important information that could help improve treatments for women dealing with PCOS.

To participate in this study, women aged 18 to 45 who have been diagnosed with PCOS or show signs of it may be eligible. Participants should have a healthy body weight and normal blood pressure, and they should not be pregnant, breastfeeding, or using certain hormonal medications. During the trial, participants can expect to receive kisspeptin and undergo some tests to monitor their hormone levels. This is an exciting opportunity to contribute to research that could lead to better understanding and management of PCOS.

Gender

FEMALE

Eligibility criteria

• • Ages 18-45 years
• • A history of clinical diagnosis of PCOS or equivalent clinical features
• • BMI \>18.5 and \<35 kg/m2
• • Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \> 90 mm Hg)
• * Laboratory studies:
• • Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration
• • Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for healthy women
• • Not using hormonal medication or willing to complete an appropriate washout for that particular medication and its 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 its method of administration
• • No excessive alcohol consumption (\>10 drinks/week) and/or ongoing use of illicit drugs
• • • Any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation
• • Not pregnant or trying to become pregnant
• • Not breastfeeding
• • No history of bilateral oophorectomy (both ovaries removed)