Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
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| ClinicalTrials.gov Identifier: NCT01699178 |
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Recruitment Status :
Completed
First Posted : October 3, 2012
Results First Posted : October 30, 2018
Last Update Posted : June 28, 2021
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Sponsor:
Clarus Therapeutics, Inc.
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.
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Brief Summary:
The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Male Hypogonadism | Drug: Oral testosterone undecanoate Drug: Transdermal testosterone gel (AndroGel) | Phase 3 |
This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an open-label study. This study contained an arm to evaluate the oral TU formulation as well as a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was included in the Phase III study and in this extension study to allow a general evaluation of comparative safety. Subjects randomized to oral TU in the Phase III study were continued on oral TU in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel therapy. This 2-year period of therapy and assessments was to provide a long-term view of the safety of oral TU and the stability of the T replacement.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 182 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men |
| Study Start Date : | August 2012 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | April 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Oral testosterone undecanoate
Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
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Drug: Oral testosterone undecanoate
Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
Other Name: Oral TU |
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Active Comparator: Transdermal testosterone gel (AndroGel)
Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
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Drug: Transdermal testosterone gel (AndroGel)
Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
Other Name: AndroGel |
Primary Outcome Measures :
- Absolute Change From Baseline in T Cholesterol [ Time Frame: Approximately 365 days ]Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
- Absolute Change From Baseline in HDL [ Time Frame: Approximately 365 days ]Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
- Absolute Change From Baseline in LDL [ Time Frame: Approximately 365 days ]Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
- Absolute Change From Baseline in Hgb [ Time Frame: Approximately 365 days ]Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
- Absolute Change From Baseline in Hct [ Time Frame: Approximately 365 days ]Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
- Absolute Change From Baseline in Prostate Volume [ Time Frame: Approximately 365 days ]Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects were to have completed Study CLAR-09007.
- Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
- Subjects were required to remain off all forms of T except for study medication throughout the entire study.
- Subjects voluntarily gave written informed consent to participate in this study.
Subjects meeting any of the following criteria were not eligible for participation in this study:
- Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness developed during the Phase III study that would, in the opinion of the Investigator, require exclusion from this study.
- Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).
- Serum transaminases >2 times upper limit of normal (ULN), serum bilirubin >2.0 mg/dL and serum creatinine >2.0 mg/dL at the final visit for Study CLAR 09007.
- Abnormal prostate digital rectal examination (palpable nodule[s]) or elevated PSA (serum PSA >4 ng/mL) at the final visit for Study CLAR-09007.
- Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or dehydroepiandrosterone (DHEA).
- Known malabsorption syndrome and/or current treatment with oral lipase inhibitors (e.g., orlistat [Xenical]) and bile acid-binding resins (e.g., cholestyramine [Questran], colestipol [Colestid]).
- Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007.
- Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g., barbiturates, glucocorticoids [pharmacologic doses of glucocorticoids for replacement therapy were not exclusionary]) and potent CYP3A4 inhibitors (e.g., human immunodeficiency virus [HIV] antivirals [indinavir, nelfinavir, ritonavir, saquinavir, delaviridine], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note: Short-term ciprofloxacin administration completed more than 7 days prior to study visits was not exclusionary during the study.)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699178
Locations
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Sponsors and Collaborators
Clarus Therapeutics, Inc.
Investigators
| Principal Investigator: | Ronald Swerdloff, MD | University of California, Los Angeles |
| Responsible Party: | Clarus Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01699178 |
| Other Study ID Numbers: |
CLAR-12010 |
| First Posted: | October 3, 2012 Key Record Dates |
| Results First Posted: | October 30, 2018 |
| Last Update Posted: | June 28, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Individual Participant data shared with associated investigational sites only. |
Additional relevant MeSH terms:
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Hypogonadism Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |