Trial Outcomes & Findings for Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men (NCT NCT03868059)
NCT ID: NCT03868059
Last Updated: 2021-06-10
Results Overview
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
COMPLETED
PHASE3
138 participants
Baseline to end of study (approximately 4 months).
2021-06-10
Participant Flow
Participant milestones
| Measure |
LPCN 1021
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Overall Study
STARTED
|
138
|
|
Overall Study
COMPLETED
|
126
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
LPCN 1021
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
Baseline characteristics by cohort
| Measure |
LPCN 1021
n=138 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 10.18 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
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Sex: Female, Male
Male
|
138 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
138 participants
n=39 Participants
|
|
Body Mass Index
|
33.12 kg/m^2
STANDARD_DEVIATION 5.75 • n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (approximately 4 months).Population: Subjects who had evaluable average 24-hour SBP measurements from Baseline to End of Study
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
Outcome measures
| Measure |
LPCN 1021
n=118 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
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|---|---|
|
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
|
3.8 mmHg
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable average daytime SBP measurements from Baseline to End of Study
Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=126 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average Daytime SBP
|
5.2 mmHg
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with evaluable average nighttime SBP measurements from Baseline to End of Study
Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=126 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average Nighttime SBP
|
4.3 mmHg
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with evaluable average 24-hour DBP measurements from Baseline to End of Study
Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=118 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
|
1.2 mmHg
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable average daytime DBP measurements from Baseline to End of Study
Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=126 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average Daytime DBP
|
1.7 mmHg
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable average nighttime DBP measurements from Baseline to End of Study
Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=126 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average Nighttime DBP
|
1.7 mmHg
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable average 24-hour PR measurements from Baseline to End of Study
Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=118 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average 24-hour Pulse Rate (PR)
|
2.0 bpm
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable average daytime PR measurements from Baseline to End of Study
Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=126 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average Daytime PR
|
2.6 bpm
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable average nighttime PR measurements from Baseline to End of Study
Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=126 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average Nighttime PR
|
0.44 bpm
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable morning SBP measurements in triplicate at the clinic at Baseline and end of Study
Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=127 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in Morning SBP Measured in Triplicate at the Clinic
|
4.8 mmHg
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable morning DBP measurements in triplicate at the clinic at Baseline and end of Study
Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=127 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in Morning DBP Measured in Triplicate at the Clinic
|
1.6 mmHg
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable morning PR measurements in triplicate at the clinic at Baseline and End of Study
Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=127 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in Morning PR Measured in Triplicate at the Clinic
|
2.0 bpm
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with evaluable patient reported sexual distress questionnaire responses
Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse)
Outcome measures
| Measure |
LPCN 1021
n=125 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in Patient Reported Sexual Distress
|
-0.3 units on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with evaluable patient reported sexual desire questionnaire responses
Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better)
Outcome measures
| Measure |
LPCN 1021
n=125 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in Patient Reported Sexual Desire
|
1.2 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)Population: Subjects with evaluable baseline and interim MRI-PDFF data, with MRI-PDFF measurement of ≥5% at baseline
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5%
Outcome measures
| Measure |
LPCN 1021
n=20 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%
|
-13.5 % Relative Change
Standard Deviation 49.0
|
SECONDARY outcome
Timeframe: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)Population: Subjects with evaluable baseline and post-treatment MRI-PDFF data, with MRI-PDFF measurement of ≥5% at baseline
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5%
Outcome measures
| Measure |
LPCN 1021
n=21 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%
|
-33.4 % Relative Change
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)Population: Subjects with evaluable baseline and interim MRI-PDFF data, with MRI-PDFF measurement of ≥10% at baseline
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10%
Outcome measures
| Measure |
LPCN 1021
n=7 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
|
-38.5 % Relative Change
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)Population: Subjects with evaluable baseline and post-treatment MRI-PDFF data, with MRI-PDFF measurement of ≥10% at baseline
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10%
Outcome measures
| Measure |
LPCN 1021
n=8 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
|
-39.7 % Relative Change
Standard Deviation 32.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects who had evaluable SBP dip measurements from Baseline to End of Study
Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=126 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change is SBP Dip
|
0.5 mmHg
Standard Deviation 9.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with a low FRS (0\<FRS\<11) who had evaluable 24-hour SBP measurements from baseline to end of study
Change in average 24-hour SBP in subjects with a low cardiovascular risk based on their Framingham Risk Score (0\<FRS\<11) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.
Outcome measures
| Measure |
LPCN 1021
n=40 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)
|
2.6 mmHg
Standard Deviation 2.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with a medium FRS (11≤FRS\<24) who had evaluable 24-hour SBP measurements from baseline to end of study
Change in average 24-hour SBP in subjects with a moderate cardiovascular risk based on their Framingham Risk Score (11≤FRS\<24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.
Outcome measures
| Measure |
LPCN 1021
n=74 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)
|
4.8 mmHg
Standard Deviation 13.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with a high FRS (FRS≥24) who had evaluable 24-hour SBP measurements from baseline to end of study
Change in average 24-hour SBP in subjects with a high cardiovascular risk based on their Framingham Risk Score (FRS≥24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.
Outcome measures
| Measure |
LPCN 1021
n=4 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)
|
-1.8 mmHg
Standard Deviation 14.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with a baseline SBP \>140mmHg who had evaluable average 24-hour SBP measurements from baseline to end of study
Change in average 24-hour SBP as measured by ABPM in subjects with a baseline SBP \>140mmHg from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=25 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg
|
-3.0 mmHg
Standard Deviation 13.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to end of Study (approximately 4 months)Population: Subjects with evaluable Hematocrit values from baseline and end of study
Change in Hematocrit (%) from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=129 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in Hematocrit From Baseline
|
3.2 percentage of hematocrit
Standard Deviation 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Study (approximately 4 months)Number of participants who had to start a new hypertensive medication or increase their hypertensive medication dose from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=138 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Study (approximately 4 months)Population: Subjects with evaluable Hemoglobin values from baseline and end of study
Change in Hemoglobin from Visit 3 to Visit 5
Outcome measures
| Measure |
LPCN 1021
n=129 Participants
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Change in Hemoglobin From Baseline
|
0.87 g/dL
Standard Deviation 1.05
|
Adverse Events
LPCN 1021
Serious adverse events
| Measure |
LPCN 1021
n=138 participants at risk
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Psychiatric disorders
Psychiatric Disorders
|
0.72%
1/138 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
0.72%
1/138 • 4 months
|
Other adverse events
| Measure |
LPCN 1021
n=138 participants at risk
LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),
LPCN 1021: LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
|
|---|---|
|
Blood and lymphatic system disorders
Polycythemia
|
1.4%
2/138 • Number of events 2 • 4 months
|
|
Vascular disorders
Hypertension
|
4.3%
6/138 • Number of events 7 • 4 months
|
|
Reproductive system and breast disorders
Gynaecomastia
|
1.4%
2/138 • Number of events 2 • 4 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.4%
2/138 • Number of events 2 • 4 months
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
1.4%
2/138 • Number of events 2 • 4 months
|
|
Nervous system disorders
Dizziness
|
1.4%
2/138 • Number of events 2 • 4 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
5/138 • Number of events 5 • 4 months
|
|
Infections and infestations
Sinusitis
|
1.4%
2/138 • Number of events 2 • 4 months
|
|
Investigations
Haematocrit increased
|
2.9%
4/138 • Number of events 4 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place