Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function

NCT00995072 | Completed Results DMC

• 1 other identifier: SAIRB-09-0011
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Female Sexual Dysfunction

Keywords

sexual dysfunction; female; hypertension; high blood pressure; beta blockers; metoprolol; nebivolol; Bystolic; Toprol XL

Outcome Measures

Primary Outcomes (1)

• Change in Female Sexual Function Index

  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.

  Baseline, 12 weeks

Secondary Outcomes (1)

• Change in Sexual Functioning Questionnaire Score

  Baseline, 12 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

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

Arm B

EXPERIMENTAL

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

Interventions

nebivolol and metoprolol succinate DRUG

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.

Also known as: nebivolol, Bystolic, metoprolol succinate, Toprol XL

Arm A

metoprolol succinate and nebivolol DRUG

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.

Also known as: nebivolol, Bystolic, metoprolol succinate, Toprol XL

Arm B

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• East Coast Institute for Research: lead

Study Sites (1)

Family Practice

Jacksonville, Florida, 32204, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension; Sexual Dysfunction, Physiological

Interventions

Nebivolol; Metoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Propanols

Limitations and Caveats

The study had a lower than anticipated enrollment and a high drop-out rate due to loss of follow-up-although the drop-out rate was not unexpected based on the study population.

Results Point of Contact

• Title: Benjamin Epstein, PharmD
• Organization: ECIR

benjamin.epstein@eastcoastresearch.net

904-854-1354

Study Officials

• Benjamin Epstein, PharmD

  East Coast Institute for Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 29, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-03

Locations

US (1)