Dampening the Reproductive Axis With Continuous Kisspeptin

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).

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome; PCOS; Reproductive Disorder
• Intervention / Treatment: Drug: kisspeptin 112-121; Drug: GnRH

Detailed Description

Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.

Delivery of Interventions:

• Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.

• On the day of the study, the subjects will have an intravenous (IV) line placed and

  • Undergo up to q10 min blood sampling x 36 hours
  • Receive an infusion of kisspeptin x 24 hours
  • Receive up to two kisspeptin IV boluses
  • Receive up to one gonadotropin-releasing hormone (GnRH) IV bolus

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 617-643-2308; Email: MGHKisspeptinResearch@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Study Coordinator; Phone Number: 617-643-2308; Email: MGHKisspeptinResearch@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: kisspeptin, GnRH; IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.	Drug: kisspeptin 112-121; IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin; Other Names: metastin 45-54; Drug: GnRH; Up to one IV bolus of GnRH; Other Names: gonadotropin-releasing hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in LH pulse frequency	Average change in LH pulse frequency before and during kisspeptin infusion	6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
Average change in LH pulse amplitude	Average change in LH pulse amplitude before and during kisspeptin infusion	6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

Collaborators and Investigators

• Sponsor: Stephanie B. Seminara, MD
• Investigators: Principal Investigator: Stephanie B Seminara, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PCOS; kisspeptin; GnRH; reproductive disorders
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 2023P001356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No