Trial Outcomes & Findings for Comparison of Two Formulations of Androxal (NCT NCT01984398)
NCT ID: NCT01984398
Last Updated: 2019-05-06
Results Overview
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
24 hours
Results posted on
2019-05-06
Participant Flow
Participant milestones
| Measure |
12.5 mg Androxal (Formulation A), Then B
During Treatment Period 1, participants were randomly assigned to a single dose of either 12.5 mg Androxal Formulation A or 12.5 mg Androxal Formulation B.
After the washout period, participants then crossed over to receive the alternate 12.5 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B.
|
12.5 mg Androxal (Formulation B), Then A
During Treatment Period 1, participants were randomly assigned to a single dose of either 12.5 mg Androxal Formulation A or 12.5 mg Androxal Formulation B.
After the washout period, participants then crossed over to receive the alternate 12.5 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B.
|
25 mg Androxal (Formulation A), Then B
During Treatment Period 1, participants were randomly assigned to a single dose of either 25 mg Androxal formulation A or 25 mg Androxal formulation B.
After the washout period, participants then crossed over to receive the alternate 25 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B.
|
25 mg Androxal (Formulation B), Then A
During Treatment Period 1, participants were randomly assigned to a single dose of either 25 mg Androxal formulation A or 25 mg Androxal formulation B.
After the washout period, participants then crossed over to receive the alternate 25 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
4
|
4
|
4
|
4
|
|
Treatment Period 1
COMPLETED
|
4
|
4
|
4
|
4
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period of 5 to 7 Days
STARTED
|
4
|
4
|
4
|
4
|
|
Washout Period of 5 to 7 Days
COMPLETED
|
4
|
4
|
4
|
4
|
|
Washout Period of 5 to 7 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
4
|
4
|
4
|
4
|
|
Treatment Period 2
COMPLETED
|
4
|
4
|
4
|
4
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Formulations of Androxal
Baseline characteristics by cohort
| Measure |
12.5 mg Androxal (Formulations A and B)
n=8 Participants
During Treatment Period 1, participants were randomly assigned to a single dose of either 12.5 mg Androxal Formulation A or 12.5 mg Androxal Formulation B.
After the washout period, participants then crossed over to receive the alternate 12.5 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B.
|
25 mg Androxal (Formulations A and B)
n=8 Participants
During Treatment Period 1, participants were randomly assigned to a single dose of either 25 mg Androxal formulation A or 25 mg Androxal formulation B.
After the washout period, participants then crossed over to receive the alternate 25 mg formulation during Treatment Period 2, ensuring all participants had received one dose of Formulation A and one dose of Formulation B.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Safety and PK populations are the same
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Outcome measures
| Measure |
12.5 mg Androxal Formulation A
n=8 Participants
A single dose of 12.5 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.
|
25 mg Androxal Formulation A
n=8 Participants
A single dose of 25 mg Androxal Formulation A, received either during Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Androxal Cmax Formulation A
|
0.999 ng/mL
Standard Deviation 0.349
|
1.67 ng/mL
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Safety and PK populations are the same
To determine and compare the PK parameter Cmax between two formulations of Androxal
Outcome measures
| Measure |
12.5 mg Androxal Formulation A
n=8 Participants
A single dose of 12.5 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.
|
25 mg Androxal Formulation A
n=8 Participants
A single dose of 25 mg Androxal Formulation A, received either during Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Androxal Cmax Formulation B
|
1.08 ng/mL
Standard Deviation 0.42
|
1.74 ng/mL
Standard Deviation 0.47
|
Adverse Events
12.5 mg Androxal Formulation A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
12.5mg Androxal Formulation B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
25 mg Androxal Formulation A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
25 mg Androxal Formulation B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
12.5 mg Androxal Formulation A
n=8 participants at risk
A single dose of 12.5 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.
|
12.5mg Androxal Formulation B
n=8 participants at risk
A single dose of 12.5 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.
|
25 mg Androxal Formulation A
n=8 participants at risk
A single dose of 25 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.
|
25 mg Androxal Formulation B
n=8 participants at risk
A single dose of 25 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
0.00%
0/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
0.00%
0/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
12.5%
1/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
0.00%
0/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
12.5%
1/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
0.00%
0/8 • From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2)
Adverse event data is presented for each Formulation (A and B) and dose (12.5mg and 25mg) of Androxal.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER