Trial Outcomes & Findings for Role of Endogenous Estrogen in Growth-Hormone Regulation in Postmenopausal Women (NCT NCT01186796)
NCT ID: NCT01186796
Last Updated: 2015-03-27
Results Overview
Averaged over 90-min baseline on the saline day.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.
Results posted on
2015-03-27
Participant Flow
Participant milestones
| Measure |
Fulvestrant Group
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Fulvestrant Group
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Role of Endogenous Estrogen in Growth-Hormone Regulation in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Fulvestrant Group
n=10 Participants
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Group
n=14 Participants
Subjects are given 3 consecutive weekly injections of Saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
14 participants
n=4 Participants
|
24 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.Averaged over 90-min baseline on the saline day.
Outcome measures
| Measure |
Fulvestrant Group
n=10 Participants
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
n=14 Participants
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Mean Baseline GH Concentration
|
0.23 ug/L
Standard Error 0.063
|
0.096 ug/L
Standard Error 0.018
|
SECONDARY outcome
Timeframe: Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated by averaging values over the 6 hour collection timeframe.
Outcome measures
| Measure |
Fulvestrant Group
n=10 Participants
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
n=14 Participants
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Mean GH Concentration (Pulsatile) in Response to Secretagogue
Pulsatile GH Response to L-arg/saline
|
22.6 ug/L/6h
Standard Error 4.1
|
17.3 ug/L/6h
Standard Error 3.8
|
|
Mean GH Concentration (Pulsatile) in Response to Secretagogue
Pulsatile GH Response to L-Arg/GHRH
|
46.6 ug/L/6h
Standard Error 7.1
|
17.4 ug/L/6h
Standard Error 7.2
|
|
Mean GH Concentration (Pulsatile) in Response to Secretagogue
Pulsatile GH Response to L-arg/ghrelin
|
66.9 ug/L/6h
Standard Error 11
|
66.8 ug/L/6h
Standard Error 8.8
|
|
Mean GH Concentration (Pulsatile) in Response to Secretagogue
Pulsatile GH Response to L-arg/ghrelin + GHRH
|
214 ug/L/6h
Standard Error 23
|
178 ug/L/6h
Standard Error 27
|
SECONDARY outcome
Timeframe: Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.
Outcome measures
| Measure |
Fulvestrant Group
n=10 Participants
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
n=14 Participants
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Mean Mass of GH Released Per Burst in Response to Secretagogue
Mean Mass of GH per Burst post L-Arg/Saline
|
12.6 ug/L
Standard Error 2.9
|
7.5 ug/L
Standard Error 1.8
|
|
Mean Mass of GH Released Per Burst in Response to Secretagogue
Mean Mass of GH per Burst post L-Arg/GHRH
|
48.4 ug/L
Standard Error 7.5
|
44.4 ug/L
Standard Error 8.9
|
|
Mean Mass of GH Released Per Burst in Response to Secretagogue
Mean Mass of GH per Burst post L-Arg/Ghrelin
|
64.7 ug/L
Standard Error 12
|
45.5 ug/L
Standard Error 8.7
|
|
Mean Mass of GH Released Per Burst in Response to Secretagogue
Mean Mass of GH per Burst post L-Arg/GHRH+Ghrelin
|
203 ug/L
Standard Error 25
|
164 ug/L
Standard Error 29
|
SECONDARY outcome
Timeframe: Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.
Outcome measures
| Measure |
Fulvestrant Group
n=10 Participants
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
n=14 Participants
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Mean Duration of GH Bursts (Mode) in Response to Secretagogue
Mean Duration of GH Bursts post L-Arg/Saline
|
18.0 min
Standard Error 0.91
|
16.3 min
Standard Error 1.4
|
|
Mean Duration of GH Bursts (Mode) in Response to Secretagogue
Mean Duration of GH Bursts post L-Arg/GHRH
|
17.6 min
Standard Error 0.45
|
15.4 min
Standard Error 0.88
|
|
Mean Duration of GH Bursts (Mode) in Response to Secretagogue
Mean Duration of GH Bursts post L-Arg/Ghrelin
|
12.8 min
Standard Error 1.1
|
12.7 min
Standard Error 1.0
|
|
Mean Duration of GH Bursts (Mode) in Response to Secretagogue
Mean Duration of GH Bursts post L-Arg/GHRH+Ghrelin
|
12.7 min
Standard Error 0.92
|
12.8 min
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.
Outcome measures
| Measure |
Fulvestrant Group
n=10 Participants
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
n=14 Participants
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Mean GH Half-Life in Response to Secretagogue
Mean GH Half-life duration post L-Arg/Saline
|
15.4 min
Standard Error 1.1
|
15.0 min
Standard Error 0.84
|
|
Mean GH Half-Life in Response to Secretagogue
Mean GH Half-life duration post L-Arg/GHRH
|
17.2 min
Standard Error 0.59
|
17.5 min
Standard Error 0.70
|
|
Mean GH Half-Life in Response to Secretagogue
Mean GH Half-life duration post L-Arg/Ghrelin
|
19.4 min
Standard Error 0.3
|
19.0 min
Standard Error 0.35
|
|
Mean GH Half-Life in Response to Secretagogue
Mean GH Half-life duration post L-Arg/GHRH+Ghrelin
|
19.0 min
Standard Error 0.53
|
19.1 min
Standard Error 0.48
|
Adverse Events
Fulvestrant Group
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Saline Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fulvestrant Group
n=14 participants at risk
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
n=15 participants at risk
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Surgical and medical procedures
Vasovagal reaction with syncope
|
7.1%
1/14 • Total adverse event data for the study was collected from 2009-2013 - or the duration of the study. For each individual, adverse event data was collected over approximately one month.
|
0.00%
0/15 • Total adverse event data for the study was collected from 2009-2013 - or the duration of the study. For each individual, adverse event data was collected over approximately one month.
|
Other adverse events
| Measure |
Fulvestrant Group
n=14 participants at risk
Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
Saline Placebo Group
n=15 participants at risk
Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:
(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
|
|---|---|---|
|
Surgical and medical procedures
Generalized malaise
|
7.1%
1/14 • Total adverse event data for the study was collected from 2009-2013 - or the duration of the study. For each individual, adverse event data was collected over approximately one month.
|
0.00%
0/15 • Total adverse event data for the study was collected from 2009-2013 - or the duration of the study. For each individual, adverse event data was collected over approximately one month.
|
|
Surgical and medical procedures
Erythema post Fulvestrant injections
|
7.1%
1/14 • Total adverse event data for the study was collected from 2009-2013 - or the duration of the study. For each individual, adverse event data was collected over approximately one month.
|
0.00%
0/15 • Total adverse event data for the study was collected from 2009-2013 - or the duration of the study. For each individual, adverse event data was collected over approximately one month.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place