NCT00695110

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

June 24, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 9, 2008

Results QC Date

April 6, 2021

Last Update Submit

June 23, 2021

Conditions

Hypogonadism

Keywords

testosteronemale hypogonadismlow testosterone

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

All study participants

EXPERIMENTAL

Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days. Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days. Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days. Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.

Drug: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)Drug: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)Drug: Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)Drug: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)

Interventions

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.

All study participants
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.

All study participants
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.

All study participants
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.

All study participants

Eligibility Criteria

Age18 Years - 68 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Alabama Internal Medicine

Birmingham, Alabama, 35235, United States

Location

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Los Angeles, California, 90502, United States

Location

dgd Research, Inc.

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7.

    PMID: 21474786DERIVED

MeSH Terms

Conditions

HypogonadismEunuchism

Interventions

testosterone undecanoatetestosterone enanthateFood

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Robert E. Dudley, PhD, CEO and President
Organization
Clarus Therapeutics, Inc.
rdudley@clarustherapeutics.com
847-562-4300

Study Officials

  • Ronald S Swerdloff, M.D.

    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    PRINCIPAL INVESTIGATOR

  • Gregory Flippo, M.D.

    Alabama Clinical Therapeutics, Inc.

    PRINCIPAL INVESTIGATOR

  • Steven J. Kulback, M.D.

    Alabama Internal Medicine

    PRINCIPAL INVESTIGATOR

  • Sherwyn Schwartz, M.D.

    dgd Research, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

August 1, 2009

Last Updated

June 25, 2021

Results First Posted

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(4)