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Administration of Kisspeptin in Patients With Hyperprolactinemia

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ClinicalTrials.gov Identifier: NCT02956447
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

Brief Summary:

The goal of this project is to explore the use of exogenous pulsatile kisspeptin as a therapeutic alternative for patients with hyperprolactinemia who are intolerant to current therapies.

Funding Source - FDA OOPD


Condition or disease Intervention/treatment Phase
Hyperprolactinemia Hypogonadism Drug: Kisspeptin 112-121 Drug: Gonadotropin Releasing Hormone (GnRH) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Kisspeptin in Patients With Hyperprolactinemia
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Kisspeptin Bolus
Administration of kisspeptin 112-121 0.24 nmol/kg intravenously (IV); 10 boluses in a 10 hour period. One bolus of GnRH at hour 11. Blood sampling every 10 minutes.
Drug: Kisspeptin 112-121
0.313 µg/kg IV
Other Name: Metastin 45-54

Drug: Gonadotropin Releasing Hormone (GnRH)
0.075 ug/kg IV
Other Name: gonadotropin-releasing hormone

No Intervention: Baseline
Blood sampling every 10 minutes
Experimental: Pulsatile kisspeptin
Administration of kisspeptin 112-121 0.24 nmol/kg IV every 90 minutes over 14 days using a portable pump. One-time bolus of kisspeptin 112-121 2.4 nmol/kg IV (if necessary).
Drug: Kisspeptin 112-121
0.313 µg/kg IV
Other Name: Metastin 45-54




Primary Outcome Measures :
  1. Change in number of luteinizing hormone (LH) pulses between Baseline and Kisspeptin Bolus arms of study. [ Time Frame: Up to 23 days ]
  2. Change in follicle size in mm by ultrasound over the course of kisspeptin administration (Arm: Pulsatile Kisspeptin) [ Time Frame: Evaluated over two weeks ]

Secondary Outcome Measures :
  1. Ovulation after high dose kisspeptin as evidenced by ultrasound (Arm: Pulsatile Kisspeptin) [ Time Frame: Up to 9 days ]
    Ultrasound evidence of corpus luteum will be used to determine if ovulation occurred



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956447


Contacts
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Contact: Isabella McDonald 617-726-8484 mghkisspeptinresearch@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Isabella McDonald    617-726-8484    mghkisspeptinresearch@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Stephanie Seminara, MD Massachusetts General Hospital

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Responsible Party: Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02956447     History of Changes
Other Study ID Numbers: 2016P002281
FD-R-5712 ( Other Grant/Funding Number: Food and Drug Administration Office of Orphan Products Development )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie B. Seminara, MD, Massachusetts General Hospital:
Kisspeptin
Hyperprolactinemia
Additional relevant MeSH terms:
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Hyperprolactinemia
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs