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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695110
• Other study ID #: CLAR-08005
• Status: Completed
• Phase: Phase 2
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: June 2021
• Source: Clarus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)
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)
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)
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)
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.

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Alabama Internal Medicine	Birmingham	Alabama
United States	Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center	Los Angeles	California
United States	dgd Research, Inc.	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Clarus Therapeutics, Inc.	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Testosterone Average Concentration (Cavg) (ng/dL)	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.	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
Primary	Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)	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.	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