Role of Endogenous Estrogen in Growth-Hormone Regulation in Postmenopausal Women

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Healthy
Interventions
DRUG

Fulvestrant

"Secretagogue combinations are assigned in randomized double-blind order within-subject to include the following four 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.~\*\*Ghrelin dosage is based on 70 kg subject.Total exposure of Ghrelin will be 42 mcg total dose for 2 subject visits (21 mcg per visit)."

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

AstraZeneca

INDUSTRY

lead

Mayo Clinic

OTHER