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Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function

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ClinicalTrials.gov Identifier: NCT00995072
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Epstein, East Coast Institute for Research

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 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 or disease Intervention/treatment Phase
Hypertension Female Sexual Dysfunction Drug: nebivolol and metoprolol succinate Drug: metoprolol succinate and nebivolol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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 Female Sexual Function
Study Start Date : October 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Female Sexual Function Index [ Time Frame: Baseline, 12 weeks ]
    This scale is a self-reported instrument used to detect female sexual function. The scale ranges from 2 to 36. The higher score indicates higher sexual function.


Secondary Outcome Measures :
  1. Change in Sexual Functioning Questionnaire Score [ Time Frame: Baseline, 12 weeks ]
    This scale is a self-reported instrument used to detect sexual functioning. The scale ranges from 14 to 70. The higher scores reflects higher sexual functioning.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995072


Locations
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United States, Florida
Family Practice
Jacksonville, Florida, United States, 32204
Sponsors and Collaborators
East Coast Institute for Research
Investigators
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Principal Investigator: Benjamin Epstein, PharmD East Coast Institute for Research
Additional Information:
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Responsible Party: Benjamin Epstein, Principal Investigator, East Coast Institute for Research
ClinicalTrials.gov Identifier: NCT00995072    
Other Study ID Numbers: SAIRB-09-0011
First Posted: October 14, 2009    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Benjamin Epstein, East Coast Institute for Research:
sexual dysfunction
female
hypertension
high blood pressure
beta blockers
metoprolol
nebivolol
Bystolic
Toprol XL
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Anti-Arrhythmia Agents
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
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists