Trial Outcomes & Findings for Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism (NCT NCT04648969)
NCT ID: NCT04648969
Last Updated: 2026-08-26
Results Overview
Change in LH amplitude before, during and after kisspeptin administration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
52 hours
Results posted on
2026-08-26
Participant Flow
Boston area. 18 participants were consented and screened for eligibility between 5/2019 and 11/2022.
There was no washout or run-in period. All participants were assigned to the same arm.
Participant milestones
| Measure |
Experimental: Kisspeptin, GnRH
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
Baseline characteristics by cohort
| Measure |
Experimental: Kisspeptin, GnRH
n=18 Participants
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 52 hoursPopulation: Seven participants completed the protocol. Eleven participants did not initiate the protocol (were ineligible, withdrew prior to start of intervention, or were lost to follow up prior to start of intervention).
Change in LH amplitude before, during and after kisspeptin administration
Outcome measures
| Measure |
Experimental: Kisspeptin, GnRH
n=7 Participants
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
|
|---|---|
|
Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin
Before vs. During
|
0.35 IU/L
Standard Deviation 0.43
|
|
Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin
Before vs. After
|
0.19 IU/L
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: 52 hoursPopulation: Seven participants completed the protocol. Eleven participants did not initiate the protocol (were ineligible, withdrew prior to start of intervention, or were lost to follow up prior to start of intervention).
Change in LH frequency before and after kisspeptin administration
Outcome measures
| Measure |
Experimental: Kisspeptin, GnRH
n=7 Participants
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
|
|---|---|
|
Average Change in LH Pulse Frequency in Response to Kisspeptin
|
0.17 # pulses/hour
Standard Deviation 0.27
|
Adverse Events
Experimental: Kisspeptin, GnRH
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Kisspeptin, GnRH
n=18 participants at risk
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis after completion of study visits
|
5.6%
1/18 • Number of events 1 • From time of study consent until removal from study participation (approximately 3 months).
All participants were asked about new health symptoms at each visit.
|
Other adverse events
| Measure |
Experimental: Kisspeptin, GnRH
n=18 participants at risk
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • From time of study consent until removal from study participation (approximately 3 months).
All participants were asked about new health symptoms at each visit.
|
|
General disorders
Fatigue
|
11.1%
2/18 • From time of study consent until removal from study participation (approximately 3 months).
All participants were asked about new health symptoms at each visit.
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18 • From time of study consent until removal from study participation (approximately 3 months).
All participants were asked about new health symptoms at each visit.
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • From time of study consent until removal from study participation (approximately 3 months).
All participants were asked about new health symptoms at each visit.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • From time of study consent until removal from study participation (approximately 3 months).
All participants were asked about new health symptoms at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place