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NCT Number: NCT00695110

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Eunuchism Gonadal Disorders

Age range

18 year–68 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Alabama Clinical Therapeutics, Birmingham, Alabama, United States

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About this study

Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters [testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, ages 18-68
  • Serum total T less than or equal to 275 ng/dL

Exclusion criteria

  • Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness.
  • Abnormal prostate digital rectal examination, elevated prostate-specific antigen (PSA), American Urological Association (AUA) symptom score of >15, and/or history of prostate cancer.
  • Hematocrit of <35 or >50%
  • Body mass index (BMI) >36
  • Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL

Treatment and study plan

Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)

Drug

Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.

Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)

Drug

Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.

Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)

Drug

Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.

Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)

Drug

Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.

Primary outcomes

  1. Serum Testosterone Average Concentration (Cavg) (ng/dL)

    Time frame: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses

    Sampling to determine serum T Cavg post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T Cavg post AM dose with food (Day 7) and fasting (Day 8) in Treatment Period 3.

  2. Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)

    Time frame: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses

    Sampling to determine serum T AUC post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T AUC with food (Day 7) and fasting (Day 8) in Treatment Period 3.

Sponsors and collaborators

Lead sponsor

Clarus Therapeutics, Inc.

Industry

Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Registry information

Official study title

Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jun 11, 2008
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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