Who is sponsoring NCT01703741?

NCT01703741 is sponsored by Ferring Pharmaceuticals.

What drugs are being tested in NCT01703741?

Interventions in NCT01703741: Testosterone Gel (FE 999093).

What condition does NCT01703741 study?

NCT01703741 studies Adult Male Hypogonadism.

Is NCT01703741 still recruiting?

NCT01703741 is currently completed. Last updated 19 September 2017.

Are results published for NCT01703741?

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

Last reviewed 2017-09-19 · How we verify

NCT01703741

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

A Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

Completed Phase 3 Results posted Last updated 19 September 2017

What this trial tests

Phase 3 trial testing Testosterone Gel (FE 999093) in Adult Male Hypogonadism in 145 participants. Completed in 1 October 2013.

Timeline

1 December 2012

Primary endpoint
1 October 2013

1 October 2013

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	145
Start date	1 December 2012
Primary completion	1 October 2013
Estimated completion	1 October 2013
Sites	18 locations across United States, Canada

Drugs / interventions tested

Testosterone Gel (FE 999093) — full drug profile →

Conditions studied

Adult Male Hypogonadism — all drugs for Adult Male Hypogonadism →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, male only, with Adult 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.

Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
Time frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics.

Sponsor's own description

This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.

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 Ferring Pharmaceuticals trials

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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 NCT01703741 (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 Ferring Pharmaceuticals
Last refreshed: 19 September 2017

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/NCT01703741.

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