Trial · NCT02956447

Administration of Kisspeptin in Patients With Hyperprolactinemia

NCT02956447, Phase 2, Completed, Massachusetts General Hospital; results first posted 2024-08-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Administration of Kisspeptin in Patients With Hyperprolactinemia. Trials, record NCT02956447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02956447

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Administration of Kisspeptin in Patients With Hyperprolactinemia
NCT number: NCT02956447
Status: Completed
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Hyperprolactinemia, Hypogonadism
Interventions: Kisspeptin 112-121, GnRH
First posted: 2016-11-07
Last updated: 2024-10-01
Results first posted: 2024-08-20

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours	Up to 14 days	No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery.	pulses per 10 hour period	MEAN
PRIMARY	Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin	Evaluated over eight days	No analysis of this outcome was performed for the Intravenous Kisspeptin Arm. These individuals did not undergo SC kisspeptin delivery.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Average Change in LH Pulse Amplitude	Up to 14 days	No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery.	mIU/mL	MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours	Intravenous Kisspeptin	3.000	Standard Deviation 3.066	pulses per 10 hour period
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin	Subcutaneous Kisspeptin	3		Participants
Average Change in LH Pulse Amplitude	Intravenous Kisspeptin	-0.5764	Standard Deviation 8.061	mIU/mL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intravenous Kisspeptin	21
Overall Study	STARTED	Subcutaneous Kisspeptin	15
Overall Study	COMPLETED	Intravenous Kisspeptin	10
Overall Study	COMPLETED	Subcutaneous Kisspeptin	5
Overall Study	NOT COMPLETED	Intravenous Kisspeptin	11
Overall Study	NOT COMPLETED	Subcutaneous Kisspeptin	10

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Intravenous Kisspeptin	5	21	6
other	Headache	Nervous system disorders	Subcutaneous Kisspeptin	2	15	5
other	Fatigue	General disorders	Intravenous Kisspeptin	2	21	2
other	Fatigue	General disorders	Subcutaneous Kisspeptin	0	15
other	Pain of skin	Skin and subcutaneous tissue disorders	Intravenous Kisspeptin	3	21	4
other	Pain of skin	Skin and subcutaneous tissue disorders	Subcutaneous Kisspeptin	2	15	2
other	Upper Respiratory Infection	Infections and infestations	Intravenous Kisspeptin	2	21	2
other	Upper Respiratory Infection	Infections and infestations	Subcutaneous Kisspeptin	2	15	2
other	Nausea	Gastrointestinal disorders	Intravenous Kisspeptin	0	21
other	Nausea	Gastrointestinal disorders	Subcutaneous Kisspeptin	1	15	1

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intravenous Kisspeptin	0	21
Total, all-cause mortality	Subcutaneous Kisspeptin	0	15
Total, other adverse events	Intravenous Kisspeptin	10	21
Total, other adverse events	Subcutaneous Kisspeptin	4	15
Total, serious adverse events	Intravenous Kisspeptin	0	21
Total, serious adverse events	Subcutaneous Kisspeptin	0	15

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intravenous Kisspeptin vs Subcutaneous Kisspeptin: deaths from any cause	Trial comparisons
Intravenous Kisspeptin vs Subcutaneous Kisspeptin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02956447

GET https://conductscience.org/api/trials/v1/NCT02956447/registered

API reference For AI assistants