Trial Outcomes & Findings for Administration of Kisspeptin in Patients With Hyperprolactinemia (NCT NCT02956447)

NCT ID: NCT02956447

Last Updated: 2024-10-01

Results Overview

Average change in LH pulse frequency at baseline and during kisspeptin IV administration

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: Up to 14 days
• Results posted on: 2024-10-01

Participant Flow

Participant milestones

Measure	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).	Subcutaneous Kisspeptin Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
Overall Study STARTED	21	15
Overall Study COMPLETED	10	5
Overall Study NOT COMPLETED	11	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Administration of Kisspeptin in Patients With Hyperprolactinemia

Baseline characteristics by cohort

Measure	Intravenous Kisspeptin n=21 Participants 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).	Subcutaneous Kisspeptin n=15 Participants Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.3 years STANDARD_DEVIATION 8.3 • n=5 Participants	30.4 years STANDARD_DEVIATION 8.4 • n=7 Participants	29.8 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	15 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days

Population: No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery.

Average change in LH pulse frequency at baseline and during kisspeptin IV administration

Outcome measures

Measure	Intravenous Kisspeptin n=11 Participants 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).	Subcutaneous Kisspeptin Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours	3.000 pulses per 10 hour period Standard Deviation 3.066	—

PRIMARY outcome

Timeframe: Evaluated over eight days

Population: No analysis of this outcome was performed for the Intravenous Kisspeptin Arm. These individuals did not undergo SC kisspeptin delivery.

Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration

Outcome measures

Measure	Intravenous Kisspeptin n=5 Participants 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).	Subcutaneous Kisspeptin Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin	3 Participants	—

SECONDARY outcome

Timeframe: Up to 14 days

Population: No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery.

Average change in LH pulse amplitude at baseline and during IV kisspeptin administration

Outcome measures

Measure	Intravenous Kisspeptin n=11 Participants 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).	Subcutaneous Kisspeptin Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
Average Change in LH Pulse Amplitude	-0.5764 mIU/mL Standard Deviation 8.061	—

Adverse Events

Intravenous Kisspeptin

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Subcutaneous Kisspeptin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intravenous Kisspeptin n=21 participants at risk 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).	Subcutaneous Kisspeptin n=15 participants at risk Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
Nervous system disorders Headache	23.8% 5/21 • Number of events 6 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	13.3% 2/15 • Number of events 5 • From the time of documented informed consent until completion of study procedures (an average of 3 months).
General disorders Fatigue	9.5% 2/21 • Number of events 2 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	0.00% 0/15 • From the time of documented informed consent until completion of study procedures (an average of 3 months).
Skin and subcutaneous tissue disorders Pain of skin	14.3% 3/21 • Number of events 4 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	13.3% 2/15 • Number of events 2 • From the time of documented informed consent until completion of study procedures (an average of 3 months).
Infections and infestations Upper Respiratory Infection	9.5% 2/21 • Number of events 2 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	13.3% 2/15 • Number of events 2 • From the time of documented informed consent until completion of study procedures (an average of 3 months).
Gastrointestinal disorders Nausea	0.00% 0/21 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	6.7% 1/15 • Number of events 1 • From the time of documented informed consent until completion of study procedures (an average of 3 months).
Nervous system disorders Dizziness	4.8% 1/21 • Number of events 1 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	6.7% 1/15 • Number of events 1 • From the time of documented informed consent until completion of study procedures (an average of 3 months).
Musculoskeletal and connective tissue disorders Muscle Cramp	4.8% 1/21 • Number of events 1 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	6.7% 1/15 • Number of events 1 • From the time of documented informed consent until completion of study procedures (an average of 3 months).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/21 • From the time of documented informed consent until completion of study procedures (an average of 3 months).	6.7% 1/15 • Number of events 1 • From the time of documented informed consent until completion of study procedures (an average of 3 months).

Additional Information

Dr. Stephanie Seminara

Massachusetts General Hospital

Phone: 617-724-5390

Email: MGHKisspeptinResearch@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place