NCT01862835 is a Phase 1 clinical trial of Degarelix in Normal Healthy Volunteers, sponsored by Mayo Clinic.

Who is sponsoring NCT01862835?

NCT01862835 is sponsored by Mayo Clinic.

What drugs are being tested in NCT01862835?

Interventions in NCT01862835: Degarelix, Testosterone, Anastrozole, Estrogen patch.

What condition does NCT01862835 study?

NCT01862835 studies Normal Healthy Volunteers.

Is NCT01862835 still recruiting?

NCT01862835 is currently completed. Last updated 5 June 2019.

Last reviewed 2019-06-05 · How we verify

NCT01862835

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Estradiol Addback on Somatostatin Rebound in Older Men

Completed Phase 1 Last updated 5 June 2019

What this trial tests

Phase 1 trial testing Degarelix in Normal Healthy Volunteers in 43 participants. Completed in 30 December 2018.

Timeline

1 May 2013

Primary endpoint
30 September 2016

30 December 2018

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	43
Start date	1 May 2013
Primary completion	30 September 2016
Estimated completion	30 December 2018
Sites	1 location across United States

Drugs / interventions tested

Degarelix (degarelix) — full drug profile →
Testosterone (TESTOSTERONE) — full drug profile →
Anastrozole (anastrozole) — full drug profile →
Estrogen patch — full drug profile →

Conditions studied

Normal Healthy Volunteers — all drugs for Normal Healthy Volunteers →

Sponsor

Mayo Clinic

Who can join

Adults 60 to 80, male only, with Normal Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

BioStatistical Analysis
Time frame: Subjects will undergo 15-h overnight (2200 - 1300 h) fasting, 10-min blood sampling
The primary analytical outcome is the summed mass of GH secreted in pulses over the 15 h of overnight blood sampling. The outcome measure is relevant, since sex-steroid hormones and regulatory peptides uniquely control GH secretory-burst mass.

Sponsor's own description

Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Degarelix

Trials testing the same drug.

NCT07335796 — A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer · Phase 2 · recruiting
NCT05873192 — Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer · Phase 2 · recruiting
NCT06378866 — Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivati · Phase 2 · recruiting
NCT06264882 — Cardiometabolic Consequences of the Loss of Ovarian Function · Phase 4 · recruiting
NCT05501704 — ETHAN - ET for Male BC · Phase 2 · recruiting

Other Mayo Clinic trials

Trials by the same sponsor.

NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men · NA · not yet recruiting
NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration · not yet recruiting
NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, · NA · not yet recruiting
NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE) · NA · recruiting
NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01862835 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 5 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01862835.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing