Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function

Sponsored by East Coast Institute for Research

About this trial

Last updated 7 years ago

Study ID

SAIRB-09-0011

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

40+ Years

Female

Trial Timing

Ended 13 years ago

What is this trial about?

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.

What are the participation requirements?

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