Trial Outcomes & Findings for Dysregulation of FSH in Obesity: Functional and Statistical Analysis (NCT NCT02478775)
NCT ID: NCT02478775
Last Updated: 2024-06-05
Results Overview
This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Every 10 minutes over 2 10-hour frequent blood sampling sessions.
Results posted on
2024-06-05
Participant Flow
Some participants were excluded after signing the consent.
Participant milestones
| Measure |
Experimental: Frequent Blood Sampling, Degarelix
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
|
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Normal weight participants = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Obese
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Obese participants = BMI of \>30
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
27
|
27
|
|
Overall Study
COMPLETED
|
6
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Baseline characteristics by cohort
| Measure |
Experimental: Frequent Blood Sampling, Degarelix
n=6 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
BMI = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Normal weight participants = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Obese
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Obese participants = BMI of \>30
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
31.9 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
BMI
|
22.5 kg/m^2
STANDARD_DEVIATION 2.5 • n=5 Participants
|
22.4 kg/m^2
STANDARD_DEVIATION 1.5 • n=7 Participants
|
37.7 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Weight
|
59.8 kg
STANDARD_DEVIATION 4.2 • n=5 Participants
|
61.1 kg
STANDARD_DEVIATION 5.4 • n=7 Participants
|
102 kg
STANDARD_DEVIATION 19.3 • n=5 Participants
|
81.6 kg
STANDARD_DEVIATION 24.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Every 10 minutes over 2 10-hour frequent blood sampling sessions.Population: The Degarelix arm is excluded because no data was collected from those participants. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm.
This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.
Outcome measures
| Measure |
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Normal weight participants = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Obese
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Obese participants = BMI of \>30
|
|---|---|---|
|
Difference Between Peak Inhibin B
|
100.8 picograms/mL
Standard Deviation 73.7
|
38.8 picograms/mL
Standard Deviation 37.9
|
SECONDARY outcome
Timeframe: Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.Population: The Degarelix arm is excluded because no data was collected from those participants. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm.
Peak inhibin B will be measured every 10 minutes during day 1 and day 2 of the study. The highest inhibin B value will be defined as the peak.
Outcome measures
| Measure |
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Normal weight participants = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Obese
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Obese participants = BMI of \>30
|
|---|---|---|
|
Peak Inhibin B Per Subject
Day 1 maximum
|
103.5 picograms/mL
Standard Deviation 43.8
|
87.5 picograms/mL
Standard Deviation 45.3
|
|
Peak Inhibin B Per Subject
Day 2 maximum
|
226.5 picograms/mL
Standard Deviation 105.3
|
126.3 picograms/mL
Standard Deviation 52.5
|
SECONDARY outcome
Timeframe: Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.Population: The Degarelix arm is excluded because no data was collected from those participants. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm.
E2 will be measured every 10 minutes on Day 1 and Day 2 of the study. The highest E2 value will be designated as the peak E2 value.
Outcome measures
| Measure |
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Normal weight participants = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Obese
n=27 Participants
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Obese participants = BMI of \>30
|
|---|---|---|
|
Peak E2 Per Subject
Day 1
|
65.1 pg/L
Standard Deviation 58.0
|
72.5 pg/L
Standard Deviation 37.7
|
|
Peak E2 Per Subject
Day 2
|
137.7 pg/L
Standard Deviation 61.8
|
99.1 pg/L
Standard Deviation 41.6
|
Adverse Events
Experimental: Frequent Blood Sampling, Degarelix
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Frequent Blood Sampling, Cetrorelix: Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Frequent Blood Sampling, Degarelix
n=6 participants at risk
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
BMI = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight
n=27 participants at risk
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Normal weight participants = 18.5 to 24.9 BMI
|
Experimental: Frequent Blood Sampling, Cetrorelix: Obese
n=27 participants at risk
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Obese participants = BMI of \>30
|
|---|---|---|---|
|
Reproductive system and breast disorders
Delay of menses
|
83.3%
5/6 • Number of events 5 • 7 Days
|
0.00%
0/27 • 7 Days
|
0.00%
0/27 • 7 Days
|
|
Reproductive system and breast disorders
Hot flashes
|
33.3%
2/6 • Number of events 2 • 7 Days
|
0.00%
0/27 • 7 Days
|
0.00%
0/27 • 7 Days
|
Additional Information
Dr. Alex Polotsky
University of Colorado School of Medicine
Phone: 303-704-8221
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place