Trial Outcomes & Findings for Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation (NCT NCT00924612)

NCT ID: NCT00924612

Last Updated: 2020-12-02

Results Overview

PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.
• Results posted on: 2020-12-02

Participant Flow

Sixteen subjects (8 at each study center) were enrolled. A total of 72 subjects were screened (16 subjects at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and 56 subjects were screened at Anapharm, beginning on April 3, 2009.

Participant milestones

Measure	Sequence ABCDE Fasting (Treatment A) followed by dose-associated breakfast meals comprised of \~ 800 calories consisting of very low fat (6-10% fat; Treatment B), low fat (20% fat; Treatment C), "normal diet" (30% fat; Treatment D), and high fat (50% fat; Treatment E). Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.	Sequence BDCEA Dose-associated breakfast meals comprised of \~ 800 calories consisting of very low fat (6-10% fat; Treatment B), followed by "normal diet" (30% fat; Treatment D), low fat (20% fat; Treatment C), high fat (50% fat; Treatment E) and fasting (Treatment A). Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.	Sequence CBEDA Dose-associated breakfast meals comprised of \~ 800 calories consisting of low fat (20% fat; Treatment C), followed by very low fat (6-10% fat; Treatment B), high fat (50% fat; Treatment E) "normal diet" (30% fat; Treatment D), and fasting (Treatment A). Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.	Sequence DBAEC Dose-associated breakfast meals comprised of \~ 800 calories consisting of "normal diet" (30% fat; Treatment D), followed by very low fat (6-10% fat; Treatment B), fasting (Treatment A), high fat (50% fat; Treatment E) and low fat (20% fat; Treatment C), Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.
Overall Study STARTED	4	4	4	4
Overall Study COMPLETED	4	4	4	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Baseline characteristics by cohort

Measure	All Study Participants n=16 Participants Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state (Treatment A) and followed by a dose-associated breakfast meal comprised of \~800 calories consisting of very low fat (6-10% fat, Treatment B), low fat (20% fat, Treatment C), normal diet (30% fat, Treatment D) and high fat (50% fat, Treatment E). Participants were randomized to one of the 4 treatment sequences (ABCDE, BDCEA, CBEDA, OR DBAEC). Oral testosterone undecanoate (containing 300 mg T)
Age, Continuous	44 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Canada	8 participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Height	174.1 centimeters STANDARD_DEVIATION 7.7 • n=5 Participants
Weight	91.1 kilograms STANDARD_DEVIATION 14.8 • n=5 Participants
BMI	30.1 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.

Population: PK population

PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.

Outcome measures

Measure	Fasting n=16 Participants Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state Oral testosterone undecanoate (containing 300 mg T)	Very Low Fat Diet n=16 Participants Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with very low fat (6-10% fat). Oral testosterone undecanoate (containing 300 mg T)	Low Fat Diet n=16 Participants Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with low fat (20% fat). Oral testosterone undecanoate (containing 300 mg T)	Normal Diet n=16 Participants Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with normal fat (30% fat). Oral testosterone undecanoate (containing 300 mg T)	High Fat Diet n=16 Participants Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with high fat (50% fat). Oral testosterone undecanoate (containing 300 mg T)
Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet	6.38 ng/dL Standard Deviation 0.456	6.73 ng/dL Standard Deviation 0.410	6.88 ng/dL Standard Deviation 0.356	7.00 ng/dL Standard Deviation 0.264	7.18 ng/dL Standard Deviation 0.312

Adverse Events

Fasting

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Very Low Fat Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Fat Diet

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal Diet

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

High Fat Diet

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fasting n=16 participants at risk Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state Oral testosterone undecanoate (containing 300 mg T)	Very Low Fat Diet n=16 participants at risk Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with very low fat (6-10% fat). Oral testosterone undecanoate (containing 300 mg T)	Low Fat Diet n=16 participants at risk Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with low fat (20% fat). Oral testosterone undecanoate (containing 300 mg T)	Normal Diet n=16 participants at risk Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with normal fat (30% fat). Oral testosterone undecanoate (containing 300 mg T)	High Fat Diet n=16 participants at risk Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with high fat (50% fat). Oral testosterone undecanoate (containing 300 mg T)
Ear and labyrinth disorders Otorrhoea	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Eye disorders Conjunctivitis	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Eye disorders Eye swelling	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Eye disorders Ocular hyperaemia	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
General disorders Catheter site pain	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	12.5% 2/16 • Number of events 2 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
General disorders Catheter site swelling	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Nervous system disorders Dysgeusia	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Nervous system disorders Headache	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Nervous system disorders Somnolence	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Respiratory, thoracic and mediastinal disorders Otopharyngeal pain	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	12.5% 2/16 • Number of events 2 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	6.2% 1/16 • Number of events 1 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	12.5% 2/16 • Number of events 2 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.	0.00% 0/16 • 3 months Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.

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