Pharmacokinetic Study to Determine Time to Steady-state

Clarus Therapeutics

Status and phase: Completed; Phase 2

Conditions: Secondary Hypogonadism; Primary Hypogonadism; Male Hypogonadism

Treatments: Drug: Testosterone undecanoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911586

CLAR-09009

Details and patient eligibility

About

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Full description

Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male, age 18-75
• Morning serum testosterone (T) <300 ng/dL on two occasions
• Naive to androgen-replacement therapy or willing to wash-out from current T therapy

Exclusion criteria

• Significant intercurrent disease
• Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
• Serum transaminases >2 times upper limit of normal
• Serum bilirubin >2.0 mg/dL
• Hematocrit <35% or >50%
• BMI >36
• Untreated, obstructive sleep apnea.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Testosterone Undecanoate

Experimental group

Description:

Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.

Treatment:

Drug: Testosterone undecanoate