Trial Outcomes & Findings for Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men (NCT NCT00695110)
NCT ID: NCT00695110
Last Updated: 2021-06-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
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
Results posted on
2021-06-25
Participant Flow
A total of 45 subjects were screened at 4 study sites (1 university medical center and 3 clinical sites). 29 hypogonadal males met all eligibility requirements and were enrolled with first study drug administration on June 13, 2008.
After signing an informed consent form, subjects underwent a screening evaluation up to 28 days prior to the first dose of study drug. 29 subjects meeting the admission criteria, began Treatment Period 1 intervention (7 days) followed by a 7-14 day washout period and then proceeded to Treatment Periods 2-4. A 7-14 day washout period occurred between successive Treatment Periods. Treatment Periods 1, 2, and 4 had intervention for 7 days and Treatment Period 3 had intervention for 8 days.
Participant milestones
| Measure |
All Study Participants
Repeat dose, single-group study including 4 treatment periods with a 7-14 day washout between successive periods:
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
|
|---|---|
|
Treatment Period 1
STARTED
|
29
|
|
Treatment Period 1
COMPLETED
|
26
|
|
Treatment Period 1
NOT COMPLETED
|
3
|
|
Treatment Period 2
STARTED
|
26
|
|
Treatment Period 2
COMPLETED
|
26
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
|
Treatment Period 3
STARTED
|
26
|
|
Treatment Period 3
COMPLETED
|
25
|
|
Treatment Period 3
NOT COMPLETED
|
1
|
|
Treatment Period 4
STARTED
|
25
|
|
Treatment Period 4
COMPLETED
|
24
|
|
Treatment Period 4
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Study Participants
Repeat dose, single-group study including 4 treatment periods with a 7-14 day washout between successive periods:
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
|
|---|---|
|
Treatment Period 1
Adverse Event
|
1
|
|
Treatment Period 1
Withdrawal by Subject
|
2
|
|
Treatment Period 3
Withdrawal by Subject
|
1
|
|
Treatment Period 4
Adverse Event
|
1
|
Baseline Characteristics
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Baseline characteristics by cohort
| Measure |
All Study Participants
n=29 Participants
Repeat dose, sequential cross-over study including 4 treatment periods with a 7-14 day washout between successive periods:
Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.
Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
|
|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Total Testosterone (ng/dL)
|
169.0 ng/dL
STANDARD_DEVIATION 82.80 • n=5 Participants
|
|
Body Mass Index (BMI) (kg/m^2)
|
30.4 kg/m^2
STANDARD_DEVIATION 3.43 • n=5 Participants
|
|
Height
|
69.9 inches
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Weight
|
212.2 pounds
STANDARD_DEVIATION 38.68 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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 dosesPopulation: All available individual serum concentrations and pharmacokinetic parameter estimates were reported; missing data were not imputed. For 1 subject in Treatment Period 1 and 1 subject in Treatment Period 4 there were insufficient data to calculate all pharmacokinetic parameters.
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.
Outcome measures
| Measure |
Treatment Period 1
n=28 Participants
Oral testosterone undecanoate (TU) (300 mg T equivalents/dose): Three capsules each containing 100 mg testosterone (T) as TU, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
|
Treatment Period 2
n=26 Participants
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.
|
Treatment Period 3
n=26 Participants
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 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.
|
Treatment Period 4
n=24 Participants
Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose): Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
|
|---|---|---|---|---|
|
Serum Testosterone Average Concentration (Cavg) (ng/dL)
Cavg (0-24)
|
792 ng/dL
Standard Deviation 254
|
654 ng/dL
Standard Deviation 230
|
—
|
541 ng/dL
Standard Deviation 289
|
|
Serum Testosterone Average Concentration (Cavg) (ng/dL)
Cavg (AM dose) with food
|
765 ng/dL
Standard Deviation 333
|
657 ng/dL
Standard Deviation 294
|
518 ng/dL
Standard Deviation 233
|
533 ng/dL
Standard Deviation 385
|
|
Serum Testosterone Average Concentration (Cavg) (ng/dL)
Cavg (PM dose) with food
|
819 ng/dL
Standard Deviation 291
|
651 ng/dL
Standard Deviation 236
|
—
|
548 ng/dL
Standard Deviation 250
|
|
Serum Testosterone Average Concentration (Cavg) (ng/dL)
Cavg (AM dose) fasting
|
—
|
—
|
241 ng/dL
Standard Deviation 106
|
—
|
PRIMARY outcome
Timeframe: 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 dosesPopulation: All available individual serum concentrations and pharmacokinetic parameter estimates were reported; missing data were not imputed. For 1 subject in Treatment Period 1 and 1 subject in Treatment Period 4 there were insufficient data to calculate all pharmacokinetic parameters.
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.
Outcome measures
| Measure |
Treatment Period 1
n=28 Participants
Oral testosterone undecanoate (TU) (300 mg T equivalents/dose): Three capsules each containing 100 mg testosterone (T) as TU, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
|
Treatment Period 2
n=26 Participants
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.
|
Treatment Period 3
n=26 Participants
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 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.
|
Treatment Period 4
n=24 Participants
Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose): Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
|
|---|---|---|---|---|
|
Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
AUC (0-12) (AM dose) with food
|
9179 (ng•hr/dL)
Standard Deviation 3990
|
7881 (ng•hr/dL)
Standard Deviation 3524
|
6217 (ng•hr/dL)
Standard Deviation 2792
|
6601 (ng•hr/dL)
Standard Deviation 4614
|
|
Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
AUC (0-24)
|
19009 (ng•hr/dL)
Standard Deviation 6102
|
15693 (ng•hr/dL)
Standard Deviation 5527
|
—
|
12980 (ng•hr/dL)
Standard Deviation 6926
|
|
Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
AUC (12-24) (PM dose) with food
|
9830 (ng•hr/dL)
Standard Deviation 3489
|
7812 (ng•hr/dL)
Standard Deviation 2837
|
—
|
2894 (ng•hr/dL)
Standard Deviation 1267
|
|
Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
AUC (0-12) (AM dose) fasting
|
—
|
—
|
2894 (ng•hr/dL)
Standard Deviation 1267
|
—
|
Adverse Events
All Study Participants
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Study Participants
n=29 participants at risk
Single group, repeat dose study including 4 treatment periods (7-8 days) and a 7-14 day washout between successive periods:
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
The primary purpose of the study was to evaluate the pharmacokinetics of T following short-term, repeat-dose administration of various T doses in the form of TU or as a combination of TU + TE (7-8 days). Consequently, the AEs represent the integrated sum over all of the treatment groups in what was short-term T exposure compared to long-term efficacy and safety evaluations. Due to the short-term exposure to each intervention, changes in laboratory parameters were assessed at the end of the overall study and not the end of each treatment intervention.
|
|---|---|
|
Infections and infestations
Osteomyelitis
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
Other adverse events
| Measure |
All Study Participants
n=29 participants at risk
Single group, repeat dose study including 4 treatment periods (7-8 days) and a 7-14 day washout between successive periods:
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days except for Day 8 when the morning dose was administered fasting.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID, 30 minutes after initiation of breakfast and dinner meals for 7 days.
The primary purpose of the study was to evaluate the pharmacokinetics of T following short-term, repeat-dose administration of various T doses in the form of TU or as a combination of TU + TE (7-8 days). Consequently, the AEs represent the integrated sum over all of the treatment groups in what was short-term T exposure compared to long-term efficacy and safety evaluations. Due to the short-term exposure to each intervention, changes in laboratory parameters were assessed at the end of the overall study and not the end of each treatment intervention.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
2/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Infections and infestations
Bronchitis
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Gastrointestinal disorders
Constipation
|
6.9%
2/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.4%
1/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Musculoskeletal and connective tissue disorders
Elbow pain
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Investigations
Increased AST and ALT
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Gastrointestinal disorders
Emesis
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
General disorders
Fatigue
|
6.9%
2/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Nervous system disorders
Headache
|
24.1%
7/29 • Number of events 8 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Gastrointestinal disorders
Gastrointestinal reflux
|
6.9%
2/29 • Number of events 3 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
General disorders
Hunger
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Nervous system disorders
Vertigo
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Psychiatric disorders
Mood altered
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.3%
3/29 • Number of events 3 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Infections and infestations
Pharyngitis
|
6.9%
2/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Infections and infestations
Upper respiratory infection
|
6.9%
2/29 • Number of events 2 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Infections and infestations
Viral herpes simplex
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.4%
1/29 • Number of events 1 • Adverse Events, whether observed by the investigator, elicited during telephone contacts and/or study visits, reported in response to a query, or reported spontaneously by the subject were recorded from time of informed consent throughout Treatment Periods 1-4 (7-8 days/period) and all 7-14 day washout periods between treatment periods totaling approximately 100 days.
|
Additional Information
Robert E. Dudley, PhD, CEO and President
Clarus Therapeutics, Inc.
Phone: 847-562-4300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. If the communication contains subject matter for which patent protection should be sought, the Sponsor will notify the PI whereupon the PI agrees to grant the Sponsor an additional 60 days to file documents necessary to protect such invention.
- Publication restrictions are in place
Restriction type: OTHER