Administration of Kisspeptin in Patients With Hyperprolactinemia

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Brief Title

Administration of Kisspeptin in Patients With Hyperprolactinemia

Official Title

Administration of Kisspeptin in Patients With Hyperprolactinemia

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
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in number of luteinizing hormone (LH) pulses between Baseline and Kisspeptin Bolus arms of study.

Secondary Outcome

 Ovulation after high dose kisspeptin as evidenced by ultrasound (Arm: Pulsatile Kisspeptin)

Condition

Hyperprolactinemia

Intervention

Kisspeptin 112-121

Study Arms / Comparison Groups

 Kisspeptin Bolus
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

September 22, 2017

Completion Date

March 31, 2022

Primary Completion Date

March 31, 2022

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.
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Stephanie Seminara, MD, 617-726-8484, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02956447

Organization ID

2016P002281

Secondary IDs

FD-R-5712

Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

Stephanie Seminara, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

July 2021