Trial Outcomes & Findings for The Effects of Aging and Estrogen on the Pituitary (NCT NCT00386022)
NCT ID: NCT00386022
Last Updated: 2017-04-13
Results Overview
LH and FSH responses to each of 4 GnRH doses, expressed as change in amplitude \[amp\] from peak to nadir between plus estrogen and baseline conditions
Recruitment status
UNKNOWN
Study phase
PHASE2/PHASE3
Target enrollment
19 participants
Primary outcome timeframe
Peak hormone level within 2 hours post GnRH doses
Results posted on
2017-04-13
Participant Flow
Participant milestones
| Measure |
Younger PMW
Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)
|
Older PMW
Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)
|
|---|---|---|
|
Baseline
STARTED
|
10
|
9
|
|
Baseline
All Doses of GnRH
|
10
|
9
|
|
Baseline
COMPLETED
|
10
|
9
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Plus Estrogen
STARTED
|
10
|
9
|
|
Plus Estrogen
Estrogen Patch
|
8
|
9
|
|
Plus Estrogen
All Doses GnRH
|
8
|
8
|
|
Plus Estrogen
COMPLETED
|
8
|
8
|
|
Plus Estrogen
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Younger PMW
Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)
|
Older PMW
Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)
|
|---|---|---|
|
Plus Estrogen
Lost to Follow-up
|
2
|
0
|
|
Plus Estrogen
Adverse Event
|
0
|
1
|
Baseline Characteristics
The Effects of Aging and Estrogen on the Pituitary
Baseline characteristics by cohort
| Measure |
Younger PMW
n=10 Participants
Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)
|
Older PMW
n=9 Participants
Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 2.46 • n=5 Participants
|
72.8 years
STANDARD_DEVIATION 2.88 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Peak hormone level within 2 hours post GnRH dosesBaseline LH and FSH responses to each of 4 GnRH doses - peak to nadir amplitude expressed as percent (%) change from nadir
Outcome measures
| Measure |
Younger PMW
n=10 Participants
Postmenopausal women aged 45-55 years studied at baseline using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
Older PMW
n=9 Participants
Postmenopausal women aged 70-80 years studied at baseline using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
|---|---|---|
|
Pituitary Response to GnRH
LH % change: 75 ng/kg GnRH
|
20.08 Percent change
Standard Error 2.94
|
17.27 Percent change
Standard Error 3.65
|
|
Pituitary Response to GnRH
LH % change: 250 ng/kg GnRH
|
62.82 Percent change
Standard Error 12.15
|
43.96 Percent change
Standard Error 5.70
|
|
Pituitary Response to GnRH
LH % change: 750 ng/kg GnRH
|
137.51 Percent change
Standard Error 14.17
|
103.73 Percent change
Standard Error 8.60
|
|
Pituitary Response to GnRH
FSH % change 25 ng/kg GnRH
|
5.30 Percent change
Standard Error .88
|
4.32 Percent change
Standard Error .89
|
|
Pituitary Response to GnRH
FSH % change: 75 ng/kg GnRH
|
8.01 Percent change
Standard Error 1.13
|
6.98 Percent change
Standard Error 1.26
|
|
Pituitary Response to GnRH
FSH % change: 250 ng/kg GnRH
|
14.57 Percent change
Standard Error 1.87
|
9.29 Percent change
Standard Error 1.32
|
|
Pituitary Response to GnRH
FSH % change: 750 ng/kg
|
23.55 Percent change
Standard Error 1.82
|
17.53 Percent change
Standard Error 2.40
|
|
Pituitary Response to GnRH
LH % change: 25 ng/kg GnRH
|
7.88 Percent change
Standard Error 1.76
|
6.00 Percent change
Standard Error 1.49
|
PRIMARY outcome
Timeframe: Peak hormone level within 2 hours post GnRH dosesLH and FSH responses to each of 4 GnRH doses, expressed as change in amplitude \[amp\] from peak to nadir between plus estrogen and baseline conditions
Outcome measures
| Measure |
Younger PMW
n=8 Participants
Postmenopausal women aged 45-55 years studied at baseline using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
Older PMW
n=8 Participants
Postmenopausal women aged 70-80 years studied at baseline using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
|---|---|---|
|
Effect of Estrogen on Pituitary Response to GnRH
LH amp change: 75 ng/kg GnRH
|
-2.9 IU/L
Standard Error 3.1
|
-0.54 IU/L
Standard Error 1.7
|
|
Effect of Estrogen on Pituitary Response to GnRH
LH amp change: 250 ng/kg GnRH
|
-17.8 IU/L
Standard Error 8.0
|
-5.4 IU/L
Standard Error 3.4
|
|
Effect of Estrogen on Pituitary Response to GnRH
LH amp change: 750 ng/kg GnRH
|
-27.1 IU/L
Standard Error 18.8
|
-14.2 IU/L
Standard Error 4.6
|
|
Effect of Estrogen on Pituitary Response to GnRH
FSH amp change: 25 ng/kg GnRH
|
-2.7 IU/L
Standard Error 1.9
|
-0.6 IU/L
Standard Error 1.3
|
|
Effect of Estrogen on Pituitary Response to GnRH
FSH amp change: 75 ng/kg
|
-6.7 IU/L
Standard Error 7.5
|
0.21 IU/L
Standard Error 1.8
|
|
Effect of Estrogen on Pituitary Response to GnRH
FSH amp change: 250 ng/kg
|
-12.1 IU/L
Standard Error 3.3
|
-1.9 IU/L
Standard Error 2.2
|
|
Effect of Estrogen on Pituitary Response to GnRH
LH amp change: 25 ng/kg GnRH
|
-0.38 IU/L
Standard Error 1.9
|
-0.53 IU/L
Standard Error 1.0
|
|
Effect of Estrogen on Pituitary Response to GnRH
FSH amp change: 750 ng/kg
|
-15.4 IU/L
Standard Error 3.9
|
-5.8 IU/L
Standard Error 3.3
|
Adverse Events
Younger PMW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Older PMW
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Younger PMW
n=10 participants at risk
Postmenopausal women aged 45-55 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
Older PMW
n=9 participants at risk
Postmenopausal women aged 70-80 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
|---|---|---|
|
Cardiac disorders
New Onset Rapid Atrial Fibrillation
|
0.00%
0/10 • 3 months
Information on AEs was collected for a 3 month period from study entry for each subject.
|
11.1%
1/9 • Number of events 1 • 3 months
Information on AEs was collected for a 3 month period from study entry for each subject.
|
Other adverse events
| Measure |
Younger PMW
n=10 participants at risk
Postmenopausal women aged 45-55 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
Older PMW
n=9 participants at risk
Postmenopausal women aged 70-80 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:
1. A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.
2. GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
fall
|
10.0%
1/10 • Number of events 1 • 3 months
Information on AEs was collected for a 3 month period from study entry for each subject.
|
0.00%
0/9 • 3 months
Information on AEs was collected for a 3 month period from study entry for each subject.
|
|
Infections and infestations
genital herpes diagnosis
|
10.0%
1/10 • Number of events 1 • 3 months
Information on AEs was collected for a 3 month period from study entry for each subject.
|
0.00%
0/9 • 3 months
Information on AEs was collected for a 3 month period from study entry for each subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place