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Administration of Kisspeptin in Patients With Hyperprolactinemia

Primary Purpose

Hyperprolactinemia, Hypogonadism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Kisspeptin 112-121
GnRH
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperprolactinemia focused on measuring Kisspeptin, Hyperprolactinemia, GnRH, Hypogonadism

Eligibility Criteria

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

Inclusion/Exclusion Criteria:

  • confirmed diagnosis of elevated levels of prolactin measured via blood test,
  • no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
  • no history of a medication reaction requiring emergency medical care,
  • no illicit drug use or excessive alcohol consumption (>10 drinks/week),
  • not currently seeking fertility, breastfeeding or pregnant,
  • no history of bilateral oophorectomy,
  • willing to complete a dopamine agonist washout and/or oral contraceptive washout,
  • normal physical exam and laboratory studies within protocol reference range.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Kisspeptin Bolus and Baseline Sampling

Pulsatile Kisspeptin

Arm Description

Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 0.24 nmol/kg intravenously (IV) in a 10-hour period and one bolus of gonadotropin-releasing hormone (GnRH) at hour 11.

Subcutaneous (SC) administration of kisspeptin 112-121 0.24 nmol/kg IV every 90 minutes over eight days using a portable pump. One-time bolus of kisspeptin 112-121 2.4 nmol/kg IV (if necessary).

Outcomes

Primary Outcome Measures

Average change in number of luteinizing hormone (LH) pulse frequency (Kisspeptin Bolus and Baseline Sampling arm)
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Change in follicle size in mm by ultrasound (Pulsatile Kisspeptin arm)
Change in follicle size in mm by ultrasound over the course of SC kisspeptin administration

Secondary Outcome Measures

Average change in LH pulse amplitude (Kisspeptin Bolus and Baseline Sampling arm)
Average change in LH pulse amplitude at baseline and during kisspeptin administration

Full Information

First Posted
November 1, 2016
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02956447
Brief Title
Administration of Kisspeptin in Patients With Hyperprolactinemia
Official Title
Administration of Kisspeptin in Patients With Hyperprolactinemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
June 28, 2023 (Actual)
Study Completion Date
July 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

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 learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). All participants will receive kisspeptin in a pulsatile fashion. Subjects in one group will attend two 12-hour visits with frequent blood draws. Subjects in the second group will wear a pump that administers kisspeptin subcutaneously (SC) over eight days and attend seven short blood sampling visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperprolactinemia, Hypogonadism
Keywords
Kisspeptin, Hyperprolactinemia, GnRH, Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kisspeptin Bolus and Baseline Sampling
Arm Type
Experimental
Arm Description
Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 0.24 nmol/kg intravenously (IV) in a 10-hour period and one bolus of gonadotropin-releasing hormone (GnRH) at hour 11.
Arm Title
Pulsatile Kisspeptin
Arm Type
Experimental
Arm Description
Subcutaneous (SC) administration of kisspeptin 112-121 0.24 nmol/kg IV every 90 minutes over eight days using a portable pump. One-time bolus of kisspeptin 112-121 2.4 nmol/kg IV (if necessary).
Intervention Type
Drug
Intervention Name(s)
Kisspeptin 112-121
Other Intervention Name(s)
Metastin 45-54
Intervention Description
0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC
Intervention Type
Drug
Intervention Name(s)
GnRH
Other Intervention Name(s)
gonadotropin-releasing hormone
Intervention Description
0.075 ug/kg IV
Primary Outcome Measure Information:
Title
Average change in number of luteinizing hormone (LH) pulse frequency (Kisspeptin Bolus and Baseline Sampling arm)
Description
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Time Frame
Up to 23 days
Title
Change in follicle size in mm by ultrasound (Pulsatile Kisspeptin arm)
Description
Change in follicle size in mm by ultrasound over the course of SC kisspeptin administration
Time Frame
Evaluated over eight days
Secondary Outcome Measure Information:
Title
Average change in LH pulse amplitude (Kisspeptin Bolus and Baseline Sampling arm)
Description
Average change in LH pulse amplitude at baseline and during kisspeptin administration
Time Frame
Up to 23 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion/Exclusion Criteria: confirmed diagnosis of elevated levels of prolactin measured via blood test, no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded, no history of a medication reaction requiring emergency medical care, no illicit drug use or excessive alcohol consumption (>10 drinks/week), not currently seeking fertility, breastfeeding or pregnant, no history of bilateral oophorectomy, willing to complete a dopamine agonist washout and/or oral contraceptive washout, normal physical exam and laboratory studies within protocol reference range.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie 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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After primary results are published, the authors will provide individual participant data upon request as long as it does not conflict with state or institutional regulations

Learn more about this trial

Administration of Kisspeptin in Patients With Hyperprolactinemia

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