Dampening the Reproductive Axis With Continuous Kisspeptin

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephanie B. Seminara, MD
• Treatments: Hormones

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 history of a medication reaction that required emergency medical care

• 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)