Effect of Nebivolol on climacteric disorders in postmenopausal women: A pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011527-31-AT

Enrollment

Registered

2009-10-13

Start date

2009-12-02

Completion date

Unknown

Last updated

2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postmenopausal women

Interventions

Trade Name: NOMEXOR 5 mg - Tabletten Product Name: NOMEXOR 5 mg - Tabletten Pharmaceutical Form: Tablet CAS Number: 152520-56-4 Other descriptive name: NEBIVOLOL HYDROCHLORIDE Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Menopausal patients (estrogen 35 mIU/ml) • The patients are sexually active • The patients have hot flushes • The patients have palpitations or extrasystoles Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigation of climacteric disorders: - Investigation of the heart rate during Nebivolol therapy - Investigation of the number of palpitations during Nebivolol therapy - Investigation of the number of hot flashes during Nebivolol therapy - Investigation of the sexual function during Nebivolol therapy ;Secondary Objective: -Investigation of the systolic and diastolic blood pressure during Nebivolol therapy -Investigation of the blood level of Endostatin during Nebivolol therapy -Investigation of the blood level of Testosterone during Nebivolol therapy ;Primary end point(s): Climacteric disorders: - Heart rate - Results of the Sexual Function Index - Results of the dairy about the number of hot flashes - Results of the dairy about the number of palpitaions	—

Measure

Time frame

Main Objective: Investigation of climacteric disorders: - Investigation of the heart rate during Nebivolol therapy - Investigation of the number of palpitations during Nebivolol therapy - Investigation of the number of hot flashes during Nebivolol therapy - Investigation of the sexual function during Nebivolol therapy ;Secondary Objective: -Investigation of the systolic and diastolic blood pressure during Nebivolol therapy -Investigation of the blood level of Endostatin during Nebivolol therapy -Investigation of the blood level of Testosterone during Nebivolol therapy ;Primary end point(s): Climacteric disorders: - Heart rate - Results of the Sexual Function Index - Results of the dairy about the number of hot flashes - Results of the dairy about the number of palpitaions

—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026