Trial Outcomes & Findings for Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function (NCT NCT00995072)
NCT ID: NCT00995072
Last Updated: 2019-03-29
Results Overview
This scale is a self-reported instrument used to detect female sexual function. The scale ranges from 2 to 36. The higher score indicates higher sexual function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2019-03-29
Participant Flow
4 subjects were randomized and dropped from the study prior to taking the study medication
Participant milestones
| Measure |
Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg
Nebivolol 5 mg daily for 12 weeks followed by Metoprolol succinate 100 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to metoprolol.
nebivolol and metoprolol succinate: Subjects randomized to treatment Arm A will receive nebivolol 5 mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm A will then receive metoprolol succinate 100 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks.
|
Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily
Metoprolol succinate 100 mg daily for 12 weeks followed by nebivolol 5 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to nebivolol.
metoprolol succinate and nebivolol: Subjects randomized to treatment Arm B will receive metoprolol succinate 100mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm B will then receive nebivolol 5 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
15
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The number analysed in rows differs from overall due to dropouts.
Baseline characteristics by cohort
| Measure |
Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg
n=9 Participants
Nebivolol 5 mg daily for 12 weeks followed by Metoprolol succinate 100 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to metoprolol.
nebivolol and metoprolol succinate: Subjects randomized to treatment Arm A will receive nebivolol 5 mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm A will then receive metoprolol succinate 100 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks.
|
Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily
n=12 Participants
Metoprolol succinate 100 mg daily for 12 weeks followed by nebivolol 5 mg daily for 12 weeks. A two week washout (no medication) is completed prior to switching to nebivolol.
metoprolol succinate and nebivolol: Subjects randomized to treatment Arm B will receive metoprolol succinate 100mg once daily for 12 weeks. After 12 weeks, double blind therapy will be discontinued and patients will undergo a wash-out period of study therapy over 2 weeks. Subjects randomized to treatment Arm B will then receive nebivolol 5 mg once daily. Subjects will continue double blind therapy for a total duration of 12 weeks.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants • The number analysed in rows differs from overall due to dropouts.
|
0 Participants
n=12 Participants • The number analysed in rows differs from overall due to dropouts.
|
0 Participants
n=21 Participants • The number analysed in rows differs from overall due to dropouts.
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=9 Participants • The number analysed in rows differs from overall due to dropouts.
|
9 Participants
n=12 Participants • The number analysed in rows differs from overall due to dropouts.
|
17 Participants
n=21 Participants • The number analysed in rows differs from overall due to dropouts.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants • The number analysed in rows differs from overall due to dropouts.
|
3 Participants
n=12 Participants • The number analysed in rows differs from overall due to dropouts.
|
4 Participants
n=21 Participants • The number analysed in rows differs from overall due to dropouts.
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
12 Participants
n=12 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 Participants
n=9 Participants
|
12 Participants
n=12 Participants
|
21 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: The number of participants analyzed for the measure are participants that had data available for both of the study periods.
This scale is a self-reported instrument used to detect female sexual function. The scale ranges from 2 to 36. The higher score indicates higher sexual function.
Outcome measures
| Measure |
Nebivolol 5 mg Daily
n=15 Participants
Nebivolol 5 mg daily for 12 weeks
|
Metoprolol Succinate 100 mg Daily
n=15 Participants
Metoprolol succinate 100 mg daily for 12 weeks
|
|---|---|---|
|
Change in Female Sexual Function Index
|
1.24 units on a scale
Standard Deviation 9.183
|
1.42 units on a scale
Standard Deviation 5.262
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The number of participants analyzed for the measure are participants that had data available for both of the study periods.
This scale is a self-reported instrument used to detect sexual functioning. The scale ranges from 14 to 70. The higher scores reflects higher sexual functioning.
Outcome measures
| Measure |
Nebivolol 5 mg Daily
n=13 Participants
Nebivolol 5 mg daily for 12 weeks
|
Metoprolol Succinate 100 mg Daily
n=13 Participants
Metoprolol succinate 100 mg daily for 12 weeks
|
|---|---|---|
|
Change in Sexual Functioning Questionnaire Score
|
2.38 units on a scale
Standard Deviation 7.600
|
0.85 units on a scale
Standard Deviation 8.315
|
Adverse Events
Nebivolol 5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metoprolol Succinate 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place