Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function
Information source: East Coast Institute for Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Female Sexual Dysfunction
Intervention: nebivolol and metoprolol succinate (Drug); metoprolol succinate and nebivolol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: East Coast Institute for Research Official(s) and/or principal investigator(s):
Benjamin Epstein, PharmD, Principal Investigator, Affiliation: East Coast Institute for Research
Overall contact:
Benjamin Epstein, PharmD, Phone: 904-854-1354, Email: benjamin.epstein@eastcoastresearch.net
Summary
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.
Clinical Details
Official title: Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in FSF and CSFQ, two validated questionnaires for assessment of sexual function.
Secondary outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Over the age of 40 years
2. Postmenopausal (according to self report of 12 consecutive months of amenorrhea,
serum FSH concentrations greater than 40 international units/L, or surgical history
consistent with menopause)
3. In a stable monogamous relationship with a male partner for at least 6 months
4. History of hypertension, treated or untreated
5. Requirement for the initiation of an anti-hypertensive agent OR addition of another
anti-hypertensive medication (according to the principal investigator and based on
clinical judgment) OR patients requiring monotherapy with an anti-hypertensive that
wish to participate in the study and are willing to undergo a two week wash-out of
current anti-hypertensive therapy
6. Provide written informed consent prior to participation.
Exclusion Criteria:
1. Properly measured clinic SBP > 170 mmHg
2. Advanced AV block
3. Severe hepatic disease
4. Heart rate < 55 beats/min (and not currently on beta blocker therapy)
5. Pregnancy or lactation
6. Heart failure with ejection fraction less than 0. 40
7. History of myocardial infarction
8. History of Raynaud's syndrome
9. Patients with alcoholism or recreational drug use will be excluded due to concerns
about the ability to comply with the study requirements.
10. Major psychiatric disorder not well controlled with treatment
11. Spinal cord injury
12. Severe respiratory disease, which in the opinion of the investigator contraindicates
BB treatment
13. Poorly controlled diabetes mellitus (≥ 9%)
14. Persistent arrhythmia
Locations and Contacts
Benjamin Epstein, PharmD, Phone: 904-854-1354, Email: benjamin.epstein@eastcoastresearch.net
Family Practice, Jacksonville, Florida 32204, United States; Recruiting
Nancy Hart, PharmD, Phone: 904-384-2240, Ext: 4280, Email: nancy.hart@eastcoastresearch.net
Benjamin J Epstein, PharmD, Principal Investigator
Rebecca K Meiners, MD, Sub-Investigator
Boyd D Evans, MD, Sub-Investigator
Vaughn R Meiners, MD, Sub-Investigator
Additional Information
Starting date: October 2009
Last updated: August 13, 2012
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