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Trial Outcomes & Findings for Recall by Genotype: Neuropeptide Stimulation (NCT NCT05901467)

NCT ID: NCT05901467

Last Updated: 2026-03-06

Results Overview

Average amplitude of LH pulses at baseline

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Hours 0-8

Results posted on

2026-03-06

Participant Flow

Boston area. 16 participants were consented and screened for eligibility between 10/2023 and 4/2024.

There was no washout or run-in period. 4 individuals were found to be ineligible by criteria.

Participant milestones

Participant milestones
Measure
Kisspeptin, GnRH
IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.
Overall Study
STARTED
16
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recall by Genotype: Neuropeptide Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Kisspeptin, GnRH
n=16 Participants
IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.
Sex: Female, Male
Female
7 Participants
n=41 Participants
Sex: Female, Male
Male
9 Participants
n=41 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=41 Participants
Race (NIH/OMB)
Asian
1 Participants
n=41 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=41 Participants
Race (NIH/OMB)
White
12 Participants
n=41 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=41 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=41 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=41 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=41 Participants
Age, Categorical
<=18 years
0 Participants
n=41 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=41 Participants
Age, Categorical
>=65 years
0 Participants
n=41 Participants

PRIMARY outcome

Timeframe: Hours 0-8

Population: No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.

Average amplitude of LH pulses at baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Hours 8-11

Population: No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.

Amplitude of LH pulse in response to kisspeptin

Outcome measures

Outcome data not reported

Adverse Events

Kisspeptin, GnRH

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Kisspeptin, GnRH
n=16 participants at risk
IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.
Infections and infestations
Upper respiratory infection
6.2%
1/16 • From time of study consent until removal from study participation (approximately 2 months).
All participants were asked about new health symptoms at each visit.

Additional Information

Stephanie Seminara

Massachusetts General Hospital

Phone: 617-726-1309

Results disclosure agreements

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