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Influence of Nebivolol on Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01161823
Recruitment Status : Unknown
Verified April 2010 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : July 14, 2010
Last Update Posted : January 12, 2016
Information provided by:
Medical University of Vienna

Brief Summary:

After menopause the coronary artery disease (CAD) risk increases rapidly to an equivalent risk of men with the same age. The rising incidence of CAD could be a subsequent decline of endogenous estrogen blood levels after the menopause. Estrogen leads to vasodilation and vasoprotection through an increase of Nitric Oxide (NO). NO deficiency results in endothelial stiffness and dysfunction with a subsequent initiation of atherosclerosis. Menopausal status is associated with an increase of the sympathetic nerve activity leading to hypertension, increased heart rate and palpitations. Recent studies show an importance of vasoactive substances (e.g. NO) in the physiology of hot flashes. Thus, hot flashes may be associated with a decreased NO production and release. Additionally, it is well known that during and after menopause women experience a change in sexual function (declined libido and increased dyspareunia) due to decreasing estrogen blood levels. Recently, a new angiostatic parameter - Endostatin (ENST) - has been shown to be involved in EC function. There is also evidence that ENST levels increase during NO stimulation. Nebivolol, a ß-blocker of the third generation, has been shown to release NO to a significant amount in the EC. It is safe and effective in reducing blood pressure to the target level. However, there is no data of the effect of Nebivolol on sexual function, on clinical symptoms (palpitations, increased heart rate and hot flashes) and ENST in postmenopausal women. The present study investigates the effect of a NO-releasing ß-blocker compared to a phytoestrogen therapy considering clinical signs of menopause such as palpitations, hot flashes and sexual functioning in postmenopausal women. Therefore, the use of a ß-blocker treatment is warranted. Further, this study tries to elucidate the role of NO release in postmenopausal symptoms and may gain new insights in the pathophysiology of hot flashes and increased sympathetic nerve activity. Thus, this trial should explore an advantage of Nebivolol therapy in contrast to a phytoestrogen therapy.

Null hypothesis: Climacteric disorders as measured by the MRS-II in patients with a Nebivolol therapy is not lower than in patients with phytoestrogen therapy. Alternative hypothesis: Climacteric disorders in patients as measured by the MRS-II with a Nebivolol therapy is lower than in patients with phytoestrogen therapy.

Condition or disease
Hot Flashes Heart Rate Blood Pressure Endostatin Sexual Function

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Nebivolol on Climacteric Disorders in Postmenopausal Women. A Randomized, Open Label Trial
Study Start Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Nebivolol

2,5mg or maximum 5mg per day
2 times 1 pill at 40mg Isoflavone per day

Primary Outcome Measures :
  1. Number of hot flashes/palpitations [ Time Frame: 3 Months, 4 appointments ]
    Number of hot flashes/palpitations during month one and month three compared between nebivolol and phytoestrogens

Secondary Outcome Measures :
  1. Hemodynamic changes [ Time Frame: 3 Months, 4 appointments ]
    Measurement of blood pressure and heart rate at baseline and every four weeks.

  2. Sexual function [ Time Frame: before and after 3 months of treatment ]
    Sexual function will be investigated by the Female Sexual Function Index (FSFI-D)

  3. Endostatin [ Time Frame: Baseline and after 3 months ]
    Blood sample of Endostatin will be drawn before and after 3 months of treatment. Endostatin, a cleavage product of collagen XVIII, inhibits angiogenesis. By decreasing neovascualtrization of atherosclerotic plaques, Endostatin might be able to stop the progression of atherosclerosis.

  4. Quality of life [ Time Frame: baseline and after 3 months ]
    Menopause Rating Scale II (MRS II) is a self-assessment scale to quantify menopausal symptoms includes 11 questions to evaluate the "quality of life" in our cohorts.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 Postmenopausal women

Inclusion Criteria:

  • Menopausal patients (estrogen <20 pg/ml and FSH >35 mIU/ml)
  • The patients are sexually active
  • The patients have hot flushes
  • The patients have palpitations or extrasystoles

Exclusion Criteria:

Contraindications for a beta-blocker therapy such as:

  • Patients with COPD
  • Patients with an AV-block
  • Patients with a bradycardia (meaning a heart rate <50 beats per minute)
  • Patients with hypotension (RR <100/80 mmHg)
  • Patients with a PAD (stage III, IV)
  • Patients with Asthma
  • Patients with Morbus Raynaud
  • Patients with a carcinoma
  • Patients, who have already been treated because of hypertension
  • Patients, who receive hormone replacement therapy

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 identifier (NCT number): NCT01161823

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Department of Cardiology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Jeanette Strametz-Juranek, MD    0043140400 ext 4618   
Principal Investigator: Jeanette Strametz-Juranek, MD         
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Jeanette Strametz-Juranek, MD MUV, Department of Internal Medicine II, Division of Cardiology

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Responsible Party: Department of Cardiology Identifier: NCT01161823    
Other Study ID Numbers: 451/2009
2009-011527-31 ( EudraCT Number )
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: April 2010
Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms