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

NCT ID: NCT05901467

Last Updated: 2025-11-18

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

2025-11-18

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=202 Participants
Sex: Female, Male Male	9 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants
Race (NIH/OMB) Asian	1 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	0 Participants n=202 Participants
Race (NIH/OMB) White	12 Participants n=202 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=202 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=202 Participants
Age, Categorical <=18 years	0 Participants n=202 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=202 Participants
Age, Categorical >=65 years	0 Participants n=202 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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place