Study of Testosterone vs Placebo in Testicular Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-06-30

Brief Summary

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The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease.

The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.

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Detailed Description

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This is a single-center, randomized, double-blind, placebo-controlled intervention study, designed to evaluate the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency.

70 subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent is signed. If a subject is suitable for participation in the trial, subject will be randomized to testosterone replacement therapy or placebo and baseline investigations will be performed. Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at the end of treatment (52 weeks) and three months after completion of treatment (week 64).

Conditions

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Metabolic Syndrome Testicular Cancer Leydig Cell Failure in Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tostran 2%

1 years treatment with transdermal Tostran 2%

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

Placebo

1 years treatment with placebo gel

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

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Testosterone

Intervention Type DRUG

Placebos

Intervention Type DRUG

Other Intervention Names

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Tostran

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* Previous treatment for testicular cancer.
* No signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy).
* Free testosterone \< the age-adjusted median and \> -2 standard deviations (SD) from the age-adjusted median and LH \> 2 SD from the age-adjusted median.

Exclusion Criteria

* Treatment with testosterone within the last 6 months.
* Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)\> 4 ng/mL), malignancy suspect prostate by digital rectal examination, Alanine aminotransferase (ALT)\> 1.5 upper reference level, Erythrocyte Volume Fraction (EVF) \> 50%.
* Breast cancer.
* Symptomatic obstructive sleep apnoea syndrome
* Heart failure \> NYHA II.
* Uncontrolled hypertension: (Systolic blood pressure \> 160 mm Hg despite antihypertensive treatment, measured at two separate occasions)
* Inability to understand information about the trial
* Participation in any other clinical trial
* Allergy for the active substance or additives in Tostran or placebo.
* Known diabetes mellitus, or diabetes mellitus detected at screening or baseline tests.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No