Dampening the Reproductive Axis With Continuous Kisspeptin

Polycystic Ovary Syndrome Clinical Trial

Official title:

Dampening the Reproductive Axis With Continuous Kisspeptin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971849
• Other study ID #: 2023P001356
• Status: Recruiting
• Phase: Phase 1
• Start date: October 6, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Study Coordinator
• Phone: 617-643-2308
• Email: MGHKisspeptinResearch[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

• 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)

Related Conditions & MeSH terms

• PCOS
• Polycystic Ovary Syndrome
• Reproductive Disorder

Intervention

Drug:
• kisspeptin 112-121
IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
• GnRH
Up to one IV bolus of GnRH

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie B. Seminara, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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