Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by East Coast Institute for Research
Sponsor:
Information provided by (Responsible Party):
Benjamin Epstein, East Coast Institute for Research
ClinicalTrials.gov Identifier:
NCT00995072
First received: October 12, 2009
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Hypertension
Female Sexual Dysfunction
Drug: nebivolol and metoprolol succinate
Drug: metoprolol succinate and nebivolol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function

Resource links provided by NLM:


Further study details as provided by East Coast Institute for Research:

Primary Outcome Measures:
  • Change in FSF and CSFQ, two validated questionnaires for assessment of sexual function. [ Time Frame: Every 12 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.
Other Names:
  • nebivolol
  • Bystolic
  • metoprolol succinate
  • Toprol XL
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.
Other Names:
  • nebivolol
  • Bystolic
  • metoprolol succinate
  • Toprol XL

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995072

Contacts
Contact: Benjamin Epstein, PharmD 904-854-1354 benjamin.epstein@eastcoastresearch.net
Contact: Nancy Hart, PharmD 904-384-2240 nancy.hart@eastcoastresearch.net

Locations
United States, Florida
Family Practice Recruiting
Jacksonville, Florida, United States, 32204
Contact: Nancy Hart, PharmD    904-384-2240 ext 4280    nancy.hart@eastcoastresearch.net   
Principal Investigator: Benjamin J Epstein, PharmD         
Sub-Investigator: Rebecca K Meiners, MD         
Sub-Investigator: Boyd D Evans, MD         
Sub-Investigator: Vaughn R Meiners, MD         
Sponsors and Collaborators
East Coast Institute for Research
Investigators
Principal Investigator: Benjamin Epstein, PharmD East Coast Institute for Research
  More Information

Additional Information:
No publications provided

Responsible Party: Benjamin Epstein, Principal Investigator, East Coast Institute for Research
ClinicalTrials.gov Identifier: NCT00995072     History of Changes
Other Study ID Numbers: SAIRB-09-0011
Study First Received: October 12, 2009
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by East Coast Institute for Research:
sexual dysfunction
female
hypertension
high blood pressure
beta blockers
metoprolol
nebivolol
Bystolic
Toprol XL

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Hypertension
Vascular Diseases
Cardiovascular Diseases
Mental Disorders
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on July 26, 2014