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Dampening the Reproductive Axis With Continuous Kisspeptin

Primary Purpose

Reproductive Disorder, PCOS, Polycystic Ovary Syndrome

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
kisspeptin 112-121
GnRH
Sponsored by
Stephanie B. Seminara, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Reproductive Disorder focused on measuring reproductive disorders, kisspeptin, PCOS, GnRH

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

kisspeptin, GnRH

Arm Description

IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.

Outcomes

Primary Outcome Measures

Average change in LH pulse frequency
Average change in LH pulse frequency before and during kisspeptin infusion
Average change in LH pulse amplitude
Average change in LH pulse amplitude before and during kisspeptin infusion

Secondary Outcome Measures

Full Information

First Posted
July 17, 2023
Last Updated
October 17, 2023
Sponsor
Stephanie B. Seminara, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05971849
Brief Title
Dampening the Reproductive Axis With Continuous Kisspeptin
Official Title
Dampening the Reproductive Axis With Continuous Kisspeptin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephanie B. Seminara, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reproductive Disorder, PCOS, Polycystic Ovary Syndrome
Keywords
reproductive disorders, kisspeptin, PCOS, GnRH

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kisspeptin, GnRH
Arm Type
Experimental
Arm Description
IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.
Intervention Type
Drug
Intervention Name(s)
kisspeptin 112-121
Other Intervention Name(s)
metastin 45-54
Intervention Description
IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
Intervention Type
Drug
Intervention Name(s)
GnRH
Other Intervention Name(s)
gonadotropin-releasing hormone
Intervention Description
Up to one IV bolus of GnRH
Primary Outcome Measure Information:
Title
Average change in LH pulse frequency
Description
Average change in LH pulse frequency before and during kisspeptin infusion
Time Frame
6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
Title
Average change in LH pulse amplitude
Description
Average change in LH pulse amplitude before and during kisspeptin infusion
Time Frame
6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
617-643-2308
Email
MGHKisspeptinResearch@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie B Seminara, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-643-2308
Email
MGHKisspeptinResearch@partners.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Dampening the Reproductive Axis With Continuous Kisspeptin

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