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A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men (inTUne)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02722278
Recruitment Status : Completed
First Posted : March 29, 2016
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Hypogonadism
Interventions Drug: Oral Testosterone Undecanoate
Drug: Axiron Testosterone Topical Solution
Enrollment 222
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Testosterone Undecanoate Axiron Testosterone Topical Solution
Hide Arm/Group Description

166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).

Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.

Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.

Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

Period Title: Overall Study
Started 166 56
Completed 154 49
Not Completed 12 7
Reason Not Completed
Withdrawal by Subject             5             3
Adverse Event             4             1
Lost to Follow-up             2             0
Protocol Violation             1             0
High PSA pre-study/ not eligible             0             1
Subject declined after tx assignment             0             1
Site closure not study related             0             1
Arm/Group Title Oral Testosterone Undecanoate Axiron Testosterone Topical Solution Total
Hide Arm/Group Description

Approximately 135 subjects will receive oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).

Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.

Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.

Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

Total of all reporting groups
Overall Number of Baseline Participants 166 56 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 56 participants 222 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
160
  96.4%
54
  96.4%
214
  96.4%
>=65 years
6
   3.6%
2
   3.6%
8
   3.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 56 participants 222 participants
51.6  (9.08) 53.4  (7.86) 52  (8.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 56 participants 222 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
166
 100.0%
56
 100.0%
222
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 56 participants 222 participants
Hispanic or Latino
25
  15.1%
15
  26.8%
40
  18.0%
Not Hispanic or Latino
141
  84.9%
41
  73.2%
182
  82.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 56 participants 222 participants
American Indian or Alaska Native
0
   0.0%
1
   1.8%
1
   0.5%
Asian
3
   1.8%
2
   3.6%
5
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
29
  17.5%
11
  19.6%
40
  18.0%
White
133
  80.1%
42
  75.0%
175
  78.8%
More than one race
1
   0.6%
0
   0.0%
1
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 166 participants 56 participants 222 participants
166
 100.0%
56
 100.0%
222
 100.0%
1.Primary Outcome
Title Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7
Hide Description [Not Specified]
Time Frame Day 105
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat study population All subjects randomized to either Oral TU or Axiron
Arm/Group Title Oral Testosterone Undecanoate Axiron Testosterone Topical Solution
Hide Arm/Group Description:

166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).

Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.

Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.

Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

Overall Number of Participants Analyzed 166 56
Measure Type: Count of Participants
Unit of Measure: Participants
145
  87.3%
48
  85.7%
2.Other Pre-specified Outcome
Title Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8
Time Frame Approximately 4.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral TU Cosyntropin Substudy Subjects Axiron Cosyntropin Substudy Subjects
Hide Arm/Group Description:
Subjects receiving Oral TU participating in cosyntropin substudy
[Not Specified]
Overall Number of Participants Analyzed 24 8
Measure Type: Count of Participants
Unit of Measure: Participants
19
  79.2%
8
 100.0%
Time Frame 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Testosterone Undecanoate Axiron Testosterone Topical Solution
Hide Arm/Group Description

166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).

Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning.

Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.

Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.

All-Cause Mortality
Oral Testosterone Undecanoate Axiron Testosterone Topical Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/166 (0.00%)      0/56 (0.00%)    
Hide Serious Adverse Events
Oral Testosterone Undecanoate Axiron Testosterone Topical Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/166 (1.20%)      0/55 (0.00%)    
Gastrointestinal disorders     
Small intestinal obstruction   1/166 (0.60%)  1 0/55 (0.00%)  0
Infections and infestations     
Periumbilical abscess   1/166 (0.60%)  1 0/55 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Oral Testosterone Undecanoate Axiron Testosterone Topical Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/166 (18.67%)      8/55 (14.55%)    
Blood and lymphatic system disorders     
Anaemia   1/166 (0.60%)  1 1/55 (1.82%)  1
Eye disorders     
Vitreous floaters   0/166 (0.00%)  0 1/55 (1.82%)  1
Gastrointestinal disorders     
Nausea   4/166 (2.41%)  4 0/55 (0.00%)  0
Dyspepsia   3/166 (1.81%)  3 0/55 (0.00%)  0
Gastrooesophageal reflux disease   3/166 (1.81%)  3 0/55 (0.00%)  0
Abdominal distension   2/166 (1.20%)  2 0/55 (0.00%)  0
Diarrhoea   2/166 (1.20%)  2 0/55 (0.00%)  0
Dry mouth   2/166 (1.20%)  2 0/55 (0.00%)  0
Eructation   2/166 (1.20%)  2 0/55 (0.00%)  0
General disorders     
Oedema Peripheral   3/166 (1.81%)  3 1/55 (1.82%)  1
Application site pain   0/166 (0.00%)  0 1/55 (1.82%)  1
Feeling jittery   0/166 (0.00%)  0 1/55 (1.82%)  1
Infusion site thrombosis   0/166 (0.00%)  0 1/55 (1.82%)  1
Infections and infestations     
Upper respiratory tract infection   6/166 (3.61%)  6 0/55 (0.00%)  0
Atypical pneumonia   2/166 (1.20%)  2 0/55 (0.00%)  0
Cellulitis   1/166 (0.60%)  1 1/55 (1.82%)  1
Sinusitis   1/166 (0.60%)  1 1/55 (1.82%)  1
Acute Sinusitis   0/166 (0.00%)  0 1/55 (1.82%)  1
Otitis Externa   0/166 (0.00%)  0 1/55 (1.82%)  1
Injury, poisoning and procedural complications     
Contusion   2/166 (1.20%)  2 0/55 (0.00%)  0
Muscle Strain   1/166 (0.60%)  1 1/55 (1.82%)  1
Overdose   1/166 (0.60%)  1 2/55 (3.64%)  3
Pelvic Facture   0/166 (0.00%)  0 1/55 (1.82%)  1
Investigations     
High Density Lipoprotein Decreased   5/166 (3.01%)  5 0/55 (0.00%)  0
Blood triglycerides increased   1/166 (0.60%)  1 0/55 (0.00%)  0
Blood pressure increased   2/166 (1.20%)  2 1/55 (1.82%)  1
Prostatic specific antigen increased   2/166 (1.20%)  2 0/55 (0.00%)  0
Haematocrit Increased   8/166 (4.82%)  8 0/55 (0.00%)  0
Weight Increased   1/166 (0.60%)  1 1/55 (1.82%)  1
Metabolism and nutrition disorders     
Diabetes mellitus   1/166 (0.60%)  1 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal Pain   2/166 (1.20%)  2 0/55 (0.00%)  0
Myalgia   2/166 (1.20%)  2 0/55 (0.00%)  0
Osteoarthritis   2/166 (1.20%)  2 0/55 (0.00%)  0
Muscle Spasms   0/166 (0.00%)  0 1/55 (1.82%)  1
Neck Pain   0/166 (0.00%)  0 1/55 (1.82%)  1
Rotator Cuff Syndrome   0/166 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders     
Headache   8/166 (4.82%)  8 1/55 (1.82%)  1
Hypoaesthesia   2/166 (1.20%)  2 0/55 (0.00%)  0
Dizziness   1/166 (0.60%)  1 1/55 (1.82%)  1
Presyncope   1/166 (0.60%)  1 1/55 (1.82%)  1
Disturbance in attention   0/166 (0.00%)  0 1/55 (1.82%)  1
Nerve Compression   0/166 (0.00%)  0 1/55 (1.82%)  1
Psychiatric disorders     
Insomnia   3/166 (1.81%)  3 0/55 (0.00%)  0
Anxiety   2/166 (1.20%)  2 1/55 (1.82%)  1
Depression   2/166 (1.20%)  2 0/55 (0.00%)  0
Libido increases   0/166 (0.00%)  0 1/55 (1.82%)  1
Renal and urinary disorders     
Hematuria   2/166 (1.20%)  2 0/55 (0.00%)  0
Pollakiuria   1/166 (0.60%)  1 1/55 (1.82%)  1
Urinary incontinence   0/166 (0.00%)  0 1/55 (1.82%)  1
Reproductive system and breast disorders     
Ejaculation disorder   0/166 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   2/166 (1.20%)  2 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash   2/166 (1.20%)  3 2/55 (3.64%)  2
Drug Eruption   0/166 (0.00%)  0 1/55 (1.82%)  1
Rash maculo-papular   0/166 (0.00%)  0 1/55 (1.82%)  1
Sunburn   0/166 (0.00%)  0 1/55 (1.82%)  1
Surgical and medical procedures     
Tooth extraction   0/166 (0.00%)  0 1/55 (1.82%)  1
Vascular disorders     
Hypertension   5/166 (3.01%)  5 0/55 (0.00%)  0
Flushing   2/166 (1.20%)  2 0/55 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theodore Danoff, MD, PhD
Organization: Clarus Therapeutics
Phone: 847-562-4300
EMail: tdanoff@clarustherapeutics.com
Layout table for additonal information
Responsible Party: Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02722278    
Other Study ID Numbers: CLAR-15012
First Submitted: February 15, 2016
First Posted: March 29, 2016
Results First Submitted: November 14, 2017
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018