Who is sponsoring NCT00924612?

NCT00924612 is sponsored by Clarus Therapeutics, Inc..

What drugs are being tested in NCT00924612?

Interventions in NCT00924612: Oral testosterone undecanoate (containing 300 mg T).

What condition does NCT00924612 study?

NCT00924612 studies Male Hypogonadism.

Is NCT00924612 still recruiting?

NCT00924612 is currently completed. Last updated 6 November 2020.

Are results published for NCT00924612?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-06 · How we verify

NCT00924612

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

Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men

Completed Phase 2 Results posted Last updated 6 November 2020

What this trial tests

Phase 2 trial testing Oral testosterone undecanoate (containing 300 mg T) in Male Hypogonadism in 16 participants. Completed in 1 July 2010.

Timeline

1 July 2009

Primary endpoint
1 September 2009

1 July 2010

Quick facts

Lead sponsor	Clarus Therapeutics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 July 2009
Primary completion	1 September 2009
Estimated completion	1 July 2010
Sites	2 locations across United States, Canada

Drugs / interventions tested

Oral testosterone undecanoate (containing 300 mg T) — full drug profile →

Conditions studied

Male Hypogonadism — all drugs for Male Hypogonadism →

Sponsor

Clarus Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 65, male only, with Male Hypogonadism. Patients with the condition only — healthy volunteers not accepted.

What's being measured

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

Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
Time frame: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.
PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.

Sponsor's own description

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

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 Clarus Therapeutics, Inc. trials

Trials by the same sponsor.

NCT03973840 — Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes · Phase 1 · completed

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 NCT00924612 (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 Clarus Therapeutics, Inc.
Last refreshed: 6 November 2020

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/NCT00924612.

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