Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function
Recruitment status was: Recruiting
|Hypertension Female Sexual Dysfunction||Drug: nebivolol and metoprolol succinate Drug: metoprolol succinate and nebivolol|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function|
- Change in FSF and CSFQ, two validated questionnaires for assessment of sexual function. [ Time Frame: Every 12 weeks. ]
- The effects of nebivolol and metoprolol on sexual function and to compare the effects of both drugs on vitality, work and life performance, and work and life satisfaction. [ Time Frame: Every 4 weeks. ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm A
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
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.
Experimental: Arm B
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 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995072
|Contact: Benjamin Epstein, PharmDfirstname.lastname@example.org|
|Contact: Nancy Hart, PharmDemail@example.com|
|United States, Florida|
|Jacksonville, Florida, United States, 32204|
|Contact: Nancy Hart, PharmD 904-384-2240 ext 4280 firstname.lastname@example.org|
|Principal Investigator: Benjamin J Epstein, PharmD|
|Sub-Investigator: Rebecca K Meiners, MD|
|Sub-Investigator: Boyd D Evans, MD|
|Sub-Investigator: Vaughn R Meiners, MD|
|Principal Investigator:||Benjamin Epstein, PharmD||East Coast Institute for Research|