Trial · Interventional

CompletedPhase 2Results postedRegistry data

Administration of Kisspeptin in Patients With Hyperprolactinemia

NCTNCT02956447Other id2016P002281Other idFD-R-5712

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 36 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 17 Nov 2017
Primary completion: 28 Jun 2023
Completion: 29 Jul 2023
First posted: 7 Nov 2016 (estimated)
Last update posted: 1 Oct 2024
Conditions: Hyperprolactinemia · Hypogonadism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2018202020222024

Ph 2
Administration of Kisspeptin in Patients With Hyperprolactinemia
NCT02956447
17 Nov 2017 to 29 Jul 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Kisspeptin 112-121Drug
GnRHDrug

Arms2

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

Primary outcomes2

Outcomes the sponsor listed as primary.

Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
Time frame · Up to 14 days
Registry description
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin
Time frame · Evaluated over eight days
Registry description
Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration

Secondary outcomes(1)

Average Change in LH Pulse Amplitude
Time frame · Up to 14 days
Registry description
Average change in LH pulse amplitude at baseline and during IV kisspeptin administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Up to 14 days

Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours

Group	Value (pulses per 10 hour period)	Spread
Intravenous Kisspeptin	3.000	3.066
Subcutaneous Kisspeptin	not posted	–

Primary outcomeCount of participants· Evaluated over eight days

Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin

Group	Value (Participants)
Subcutaneous Kisspeptin	3
Intravenous Kisspeptin	not posted

Secondary and other outcome results(1)

Secondary outcomeMean· Up to 14 days

Average Change in LH Pulse Amplitude

Group	Value (mIU/mL)	Spread
Intravenous Kisspeptin	-0.5764	8.061
Subcutaneous Kisspeptin	not posted	–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Intravenous KisspeptinBlood 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).	0 / 21	0 / 21	10 / 21
Subcutaneous KisspeptinSubcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.	0 / 15	0 / 15	4 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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