Status:
COMPLETED
Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function
Lead Sponsor:
East Coast Institute for Research
Conditions:
Hypertension
Female Sexual Dysfunction
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief 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 th...
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 wome...
Eligibility Criteria
Inclusion
- Over the age of 40 years
- 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)
- In a stable monogamous relationship with a male partner for at least 6 months
- History of hypertension, treated or untreated
- 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
- Provide written informed consent prior to participation.
Exclusion
- Properly measured clinic SBP \> 170 mmHg
- Advanced AV block
- Severe hepatic disease
- Heart rate \< 55 beats/min (and not currently on beta blocker therapy)
- Pregnancy or lactation
- Heart failure with ejection fraction less than 0.40
- History of myocardial infarction
- History of Raynaud's syndrome
- Patients with alcoholism or recreational drug use will be excluded due to concerns about the ability to comply with the study requirements.
- Major psychiatric disorder not well controlled with treatment
- Spinal cord injury
- Severe respiratory disease, which in the opinion of the investigator contraindicates BB treatment
- Poorly controlled diabetes mellitus (≥ 9%)
- Persistent arrhythmia
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00995072
Start Date
October 1 2009
End Date
April 1 2013
Last Update
March 29 2019
Active Locations (1)
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1
Family Practice
Jacksonville, Florida, United States, 32204