Combined Antihypertensive Therapy and Sexual Dysfunction
Information source: LanZhou University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Sexual Dysfunction
Intervention: Felodipine add Irbesartan (Drug); Felodipine add Metoprolol (Drug)
Phase: Phase 4
Sponsored by: LanZhou University
Official(s) and/or principal investigator(s):
Jing Yu, Professor, Study Chair, Affiliation: The Second Hospital of Lanzhou University
Jing Yu, Professor, Phone: +86 0931 8942076, Email: firstname.lastname@example.org
This randomized,active controlled study aimed to compare the effects on sexual function of
treatment with combined antihypertensive drugs.
The researchers hypothesize that:
1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are
effective in lowing blood pressure in patients with essential hypertension.
2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of
sex hormone,whereas felodipine-irbesartan combination does not impair sexual function
and does not change hormone levels.
3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan
combination has a greater impact on oxidative stress indicators than
Official title: Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Female Sexual Function Index (FSFI)
International Index of Erectile Function(IIEF)
Change of Systolic Blood Pressure in 2 Weeks
Change of Systolic Blood Pressure in 4 Weeks
Change of Systolic Blood Pressure in 8 Weeks
Change of Systolic Blood Pressure in 12 Weeks
Change of Systolic Blood Pressure in 24 Weeks
Change of Systolic Blood Pressure in 48 Weeks
Change of Diastolic Blood Pressure in 2 Weeks
Change of Diastolic Blood Pressure in 4 Weeks
Change of Diastolic Blood Pressure in 8 Weeks
Change of Diastolic Blood Pressure in 12 Weeks
Change of Diastolic Blood Pressure in 24 Weeks
Change of Diastolic Blood Pressure in 48 Weeks
Serum Estradiol in 24 Weeks
Serum Estradiol in 48 Weeks
Serum Testosterone in 24 Weeks
Serum Testosterone in 48 Weeks
Serum MDA in 24 Weeks
Serum MDA in 48 Weeks
Serum 8-OHdG in 24 Weeks
Serum 8-OHdG in 48 Weeks
Serum HNE in 24 Weeks
Serum HNE in 48 Weeks
The effects of hypertension and its pharmacotherapy on sexual function are well known in
men,although this topic remains unexplored in women. There is evidence suggests that some
classes of antihypertensive drugs such as diuretics and beta-blockers have more negative
impact on male sexual function than other classes such as calcium channel blockers(CCBs) and
angiotensin-converting enzyme inhibitors(ACEI).Some data suggest that angiotensin Ⅱ
antagonists（ARBs) not only do not exacerbate sexual function in males,but even improve it.
Treatment with multiple antihypertensive medications was often necessary to attain
blood-pressure goals recommended by guidelines. More than two third of patients with 2 or 3
degree of essential hypertension require combination therapy at the beginning of treatment
to avoid target organ damage and to minimize the accidence of adverse events.
CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic
for the treatment of hypertension. The purpose of this study is to compare the impacts of
different CCB-based antihypertensive drugs combination on sexual behavior in both male and
female patients with essential hypertension,thus provide evidences for physicians to
increase patients adherence to the treatment regimens beside lowing blood pressure.
Minimum age: 18 Years.
Maximum age: 60 Years.
- Patients with essential hypertension.
- Initial hypertension, or without taking any antihypertensive for at least one month.
- Sexual active.
- Patients with secondary hypertension.
- Patients with malignant hypertension, coronary heart disease, diabetes, a history of
syncope, bradycardia (heart rate <45 beats / min), atrioventricular block(Ⅱ or Ⅲ
degree), sick sinus syndrome, congestive heart failure, a history of cerebral
vascular accidents, serious hepatic and kidney dysfunction, a history of serious
mental illness, pregnant, taking oral exogenous estrogens (including contraceptives),
hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious
conflict with sexual partner, severity sexual dysfunction.
- Patients refuse to answer questions, refuse to fill in the questionaires,or do not
willing to take blood examination.
Locations and Contacts
Jing Yu, Professor, Phone: +86 0931 8942076, Email: email@example.com
The Second Hospital of Lanzhou University, Lanzhou, Gansu 730000, China; Recruiting
Ruixin Ma, Doctor, Phone: +86 13893102690, Email: firstname.lastname@example.org
Jing Yu, Professor, Phone: +86 13893607559, Email: email@example.com
Jing Yu, Professor, Principal Investigator
Ruixin Ma, Doctor, Sub-Investigator
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Starting date: April 2008
Last updated: November 10, 2010