Administration of Kisspeptin in Patients With Hyperprolactinemia

Learn more about:
Related Clinical Trial
Administration of Kisspeptin to Subjects With Reproductive Disorders The Luveris In Vitro Fertilization Trial A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders Pituitary Function and Spontaneous Intracranial Hypotension Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility Aripiprazole and Prolactin Study Reversal of Antipsychotic-Induced Hyperprolactinemia, Weight Gain, Hyperglycemia and Dyslipidemia Characterization of Macroprolactinemia Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) Endometriosis Patients Undergoing Quinagolide Treatment Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine Peony-Glycyrrhiza Decoction (PGD) for Antipsychotic-induced Hyperprolactinemia in Patients With Schizophrenia Substrate Metabolism and Insulin Sensitivity in Patients With Hyperprolactinemia Before and After Treatment Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire Hyperprolactinemia and Adrenal Steroidogenesis Administration of Kisspeptin in Patients With Hyperprolactinemia Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

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

      Funding Source - FDA OOPD

Study Phase

Phase 2

Study Type


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)




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.


* 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


Estimated Enrollment


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.




18 Years - 45 Years

Accepts Healthy Volunteers



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

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Study Sponsor

Stephanie Seminara, MD, Principal Investigator, Massachusetts General Hospital

Verification Date

July 2021