Administration of Kisspeptin in Patients With Hyperprolactinemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2023-07-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

NCT04648969

Hypogonadotropic Hypogonadism

COMPLETED PHASE2

Kisspeptin in the Evaluation of Delayed Puberty

NCT01438034

Delayed Puberty Kallmann Syndrome Hypogonadotropic Hypogonadism +1 more

COMPLETED PHASE1

Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet

NCT02049671

Hypopituitary Adults

UNKNOWN

Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

NCT01990560

Mild Hypercortisolism

COMPLETED PHASE4

Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism

NCT00493961

Kallmann Syndrome Idiopathic Hypogonadotropic Hypogonadism GnRH Deficiency

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperprolactinemia Hypogonadism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous Kisspeptin

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 intravenously (IV).

Group Type EXPERIMENTAL

Kisspeptin 112-121

Intervention Type DRUG

0.313 ug/kg - 2 ug/kg IV or SC

GnRH

Intervention Type DRUG

0.075 ug/kg IV

Subcutaneous Kisspeptin

Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.

Group Type EXPERIMENTAL

Kisspeptin 112-121

Intervention Type DRUG

0.313 ug/kg - 2 ug/kg IV or SC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kisspeptin 112-121

0.313 ug/kg - 2 ug/kg IV or SC

Intervention Type DRUG

GnRH

0.075 ug/kg IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Metastin 45-54 gonadotropin-releasing hormone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No