An interventional study of nebivolol and metoprolol succinate and metoprolol succinate and nebivolol in Hypertension and Female Sexual Dysfunction, sponsored by East Coast Institute for Research. Completed at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by East Coast Institute for Research · Not applicable, Interventional, and Treatment
Beta-blockers (BB) are an important treatment for high blood pressure and heart disease. However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits successful use of this class of medications. Sexual side effects often result in drug discontinuation, compromising therapy goals. The investigators are conducting the study to determine if nebivolol, a newer beta blocker that is selective for receptors in the heart and causes vasodilation in the body causes fewer sexual side effects, or even improves sexual function, compared with metoprolol succinate.
This protocol is designed to compare the effects two beta blockers, nebivolol (Bystolic) 5-10 mg daily with metoprolol succinate (Toprol XL) 100-200 mg daily on sexual function in post-menopausal women with high blood pressure. The study is composed of 2 treatment phases. At baseline subjects are randomized to either nebivolol 5 mg once daily or metoprolol succinate 100 mg once daily. After randomization, subjects are treated for 12 weeks with double blind therapy. Following double-blind therapy subjects enter a 2-week washout phase and are subsequently switched to the alternate therapy.
After 4 weeks (visits 3 and 7) of double-blind treatment with either nebivolol 5 mg once daily or metoprolol succinate 100 mg once daily subjects will be evaluated and the need for dosage titration assessed. If blood pressure is not at goal the dosage of study medication will be doubled to nebivolol 10 mg once daily or metoprolol succinate 200 mg once daily. If blood pressure remains uncontrolled after 8 weeks of double blind treatment with study medication open label amlodipine 5 mg will be initiated (visits 4 and 8) at the discretion of the principal investigator. During double blind treatment subjects will be evaluated in clinic every 4 weeks.
The primary efficacy variable is the change from baseline in Changes in Sexual Functioning Questionnaire (CSFQ) and the Female Sexual Function Index (FSFI).
The primary study objective is to determine whether nebivolol causes fewer sexual side effects compared with metoprolol succinate and if nebivolol improves FSF in women. FSF will be assessed with the above questionnaires-FSFI and CSFQ.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 29 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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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.
Drug: nebivolol and metoprolol succinate
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.
Drug: metoprolol succinate and nebivolol
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.
Also known as: nebivolol, Bystolic, metoprolol succinate, Toprol XL
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.
Also known as: nebivolol, Bystolic, metoprolol succinate, Toprol XL
Change in Female Sexual Function Index
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.
Time frame: Baseline, 12 weeks
Change in Sexual Functioning Questionnaire Score
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.
Time frame: Baseline, 12 weeks
| Milestone | Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg | Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily |
|---|---|---|
| Started | 10 | 15 |
| Completed | 9 | 12 |
| Not completed | 1 | 3 |
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.
| units on a scale | Nebivolol 5 mg Daily | Metoprolol Succinate 100 mg Daily |
|---|---|---|
| Change in Female Sexual Function Index | 1.24 ± 9.183 | 1.42 ± 5.262 |
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.
| units on a scale | Nebivolol 5 mg Daily | Metoprolol Succinate 100 mg Daily |
|---|---|---|
| Change in Sexual Functioning Questionnaire Score | 2.38 ± 7.600 | 0.85 ± 8.315 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebivolol 5 mg | 0/25 (0%) | — | — |
| Metoprolol Succinate 100 mg | 0/25 (0%) | — | — |
| Age, Categorical(Participants) | Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg | Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 17 |
| >=65 years | 1 | 3 | 4 |
| Sex: Female, Male(Participants) | Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg | Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily | Total |
|---|---|---|---|
| Female | 9 | 12 | 21 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg | Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Nebivolol 5 mg Daily First, Then Metoprolol Succinate 100 mg | Metoprolol Succinate 100 mg First, Then Nebivolol 5 mg Daily | Total |
|---|---|---|---|
| United States | 9 | 12 | 21 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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East Coast Institute for Research