Trial Outcomes & Findings for Pharmacokinetic Study to Determine Time to Steady-state (NCT NCT00911586)

NCT ID: NCT00911586

Last Updated: 2020-12-11

Results Overview

Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: pre-dose on Days 1, 3, 5, 6, and 7
• Results posted on: 2020-12-11

Participant Flow

Participant milestones

Measure	Testosterone Undecanoate Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Study to Determine Time to Steady-state

Baseline characteristics by cohort

Measure	Testosterone Undecanoate n=15 Participants Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days
Age, Continuous	46.7 years STANDARD_DEVIATION 10.87 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: pre-dose on Days 1, 3, 5, 6, and 7

Population: All participants were included in the analysis population

Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.

Outcome measures

Measure	Testosterone Undecanoate n=15 Participants Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate
Serum T Concentration at Steady State	-4.077 ng/dL Standard Error 16.020

PRIMARY outcome

Timeframe: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28

Population: All participants were included in the analysis population

Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment.

Outcome measures

Measure	Testosterone Undecanoate n=15 Participants Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate
Serum T Concentration at Steady-State	4.114 ng/dL Standard Error 18.456

Adverse Events

Testosterone Undecanoate

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Testosterone Undecanoate n=15 participants at risk Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days
Gastrointestinal disorders Belching	6.7% 1/15 • Number of events 1 • 2 months
Metabolism and nutrition disorders Gout Flareup	6.7% 1/15 • Number of events 1 • 2 months
General disorders Irritabililty	6.7% 1/15 • Number of events 1 • 2 months
General disorders Lower Extremity Edema	6.7% 1/15 • Number of events 1 • 2 months
Musculoskeletal and connective tissue disorders Knee pain	6.7% 1/15 • Number of events 1 • 2 months
Respiratory, thoracic and mediastinal disorders Sinus congestion	6.7% 1/15 • Number of events 1 • 2 months
Infections and infestations Sore throat	6.7% 1/15 • Number of events 1 • 2 months
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	6.7% 1/15 • Number of events 1 • 2 months
Renal and urinary disorders Urinary tract infection	6.7% 1/15 • Number of events 1 • 2 months
Infections and infestations Viral infection	6.7% 1/15 • Number of events 1 • 2 months
Nervous system disorders Worsening sciatica	6.7% 1/15 • Number of events 1 • 2 months
Gastrointestinal disorders Stomach bloating	6.7% 1/15 • Number of events 1 • 2 months
Renal and urinary disorders Nocturia	6.7% 1/15 • Number of events 1 • 2 months

Additional Information

Robert E. Dudley, PhD, CEO and President

Clarus Therapeutics, Inc.

Phone: 847-562-4300

Email: rdudley@clarustherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place