NCT03091348 is a Phase 4 clinical trial of Testosterone in Testosterone Deficiency, sponsored by Men's Health Boston.

Who is sponsoring NCT03091348?

NCT03091348 is sponsored by Men's Health Boston.

What drugs are being tested in NCT03091348?

Interventions in NCT03091348: Testosterone.

What condition does NCT03091348 study?

NCT03091348 studies Testosterone Deficiency, Hypogonadism, Male.

Is NCT03091348 still recruiting?

NCT03091348 is currently completed. Last updated 8 October 2019.

Are results published for NCT03091348?

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

Last reviewed 2019-10-08 · How we verify

NCT03091348

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

Subcutaneous vs. Intramuscular Testosterone

Completed Phase 4 Results posted Last updated 8 October 2019

What this trial tests

Phase 4 trial testing Testosterone in Testosterone Deficiency in 4 participants. Completed in 2 January 2018.

Timeline

29 August 2017

Primary endpoint
21 November 2017

2 January 2018

Quick facts

Lead sponsor	Men's Health Boston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	29 August 2017
Primary completion	21 November 2017
Estimated completion	2 January 2018
Sites	1 location across United States

Drugs / interventions tested

Testosterone (TESTOSTERONE) — full drug profile →

Conditions studied

Testosterone Deficiency — all drugs for Testosterone Deficiency →
Hypogonadism, Male — all drugs for Hypogonadism, Male →

Sponsor

Men's Health Boston — full company profile →

Who can join

Adults 18 to 90, male only, with Testosterone Deficiency or Hypogonadism, Male. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Levels of Serum Total Testosterone Concentration Primary · "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Blood samples measured by Beckman assays and equipment.

visit 2

Group	Value	95% CI
"SQ"	NA
"IM"	1043.6

visit 3

Group	Value	95% CI
"SQ"	NA
"IM"	785.7

visit 4

Group	Value	95% CI
"SQ"	203.5
"IM"	NA

vist 5

Group	Value	95% CI
"SQ"	1367.9
"IM"	NA

visit 6

Group	Value	95% CI
"SQ"	980.8
"IM"	NA

visit 7

Group	Value	95% CI
"SQ"	144.7
"IM"	NA

Change in Levels of Serum Calculated Free T Concentration Primary · "Last visit ( Visit 7)"

Blood samples measured by Beckman assays and equipment.

Group	Value	95% CI
"SQ"	0.84
"IM"	14.74

Change in Levels of Serum Estradiol Secondary · "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Blood samples measured by Beckman assays and equipment.

visit 2

Group	Value	95% CI
"SQ"	NA
"IM"	70.03

visit 3

Group	Value	95% CI
"SQ"	NA
"IM"	52.00

visit 4

Group	Value	95% CI
"SQ"	30.06
"IM"	NA

visit 5

Group	Value	95% CI
"SQ"	45.12
"IM"	NA

visit 6

Group	Value	95% CI
"SQ"	64.74
"IM"	NA

visit 7

Group	Value	95% CI
"SQ"	25.99
"IM"	NA

Change in Levels of Serum LH Secondary · "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Blood samples measured by Beckman assays and equipment.

visit 2

Group	Value	95% CI
"SQ"	NA
"IM"	0.4

visit 3

Group	Value	95% CI
"SQ"	NA
"IM"	0.3

visit 4

Group	Value	95% CI
"SQ"	0.2
"IM"	NA

visit 5

Group	Value	95% CI
"SQ"	0.04
"IM"	NA

visit 6

Group	Value	95% CI
"SQ"	0.1
"IM"	NA

visit 7

Group	Value	95% CI
"SQ"	0.4
"IM"	NA

Change in Levels of Serum FSH Secondary · "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Blood samples measured by Beckman assays and equipment.

visit 2

Group	Value	95% CI
"SQ"	NA
"IM"	1.3

visit 3

Group	Value	95% CI
"SQ"	NA
"IM"	0.4

visit 4

Group	Value	95% CI
"SQ"	0.2
"IM"	NA

visit 5

Group	Value	95% CI
"SQ"	0.1
"IM"	NA

visit 6

Group	Value	95% CI
"SQ"	0.05
"IM"	NA

visit 7

Group	Value	95% CI
"SQ"	0.3
"IM"	NA

Change in Levels of Serum SHBG Secondary · "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Blood samples measured by Beckman assays and equipment.

visit 2

Group	Value	95% CI
"SQ"	NA
"IM"	25.5

visit 3

Group	Value	95% CI
"SQ"	NA
"IM"	22

visit 4

Group	Value	95% CI
"SQ"	27.8
"IM"	NA

visit 5

Group	Value	95% CI
"SQ"	24.8
"IM"	NA

visit 6

Group	Value	95% CI
"SQ"	22.9
"IM"	NA

visit 7

Group	Value	95% CI
"SQ"	20.7
"IM"	NA

Change in Level of Serum PSA Secondary · "Last visit (Visit 7)"

Blood samples measured by Beckman assays and equipment.

Group	Value	95% CI
"SQ"	0.25
"IM"	0.02

Change in Levels of Whole Blood Hematocrit Secondary · "Last visit (Visit 7)"

Blood samples measured by Quest assays and equipment.

Group	Value	95% CI
"SQ"	NA
"IM"	1.9

Sponsor's own description

In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. The primary objective of this study is to measure testosterone concentration in men after these two treatment routes and determine if there are any significant differences due to modes of administration. Endpoints will include total serum testosterone and calculated free testosterone. A questionnaire will also be administered to assess overall patient experience with each route of administration.

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 Testosterone

Trials testing the same drug.

NCT07212712 — The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans · NA · not yet recruiting
NCT04675788 — Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening · Phase 4 · completed
NCT06149065 — Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study · completed
NCT02938923 — Starting a Testosterone and Exercise Program After Hip Injury · Phase 3 · completed
NCT05781685 — The Influence of Testosterone on Experimental Pain Perception · EARLY_PHASE1 · completed

Other recruiting trials for Testosterone Deficiency

Currently open trials in the same condition.

NCT06343870 — Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME) · Phase 3 · recruiting
NCT07227740 — Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury · recruiting
NCT06841328 — Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes · recruiting
NCT04460872 — Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury · Phase 2 · recruiting
NCT06794346 — Sexual Effects of Transdermal or Vaginal Testosterone · Phase 2 · active not recruiting

Other Men's Health Boston trials

Trials by the same sponsor.

NCT03815331 — Xiaflex® Plus Testosterone Treatment Pilot Study Protocol · Phase 4 · completed
NCT03091296 — Diurnal Testosterone Concentration · completed
NCT01578473 — Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease · 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 NCT03091348 (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 Men's Health Boston
Last refreshed: 8 October 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/NCT03091348.

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

NCT03091348

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Testosterone

Other recruiting trials for Testosterone Deficiency

Other Men's Health Boston trials

Verify against primary sources