Clinical trial NCT01238705: Combined Antihypertensive Therapy and Sexual Dysfunction
Official title: Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Sexual Dysfunction
Keywords: Hypertension
Antihypertensive Agents
Combination
Sexual Dysfunction
Oxidative Stress
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 felodipine-metoprolol combination.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with essential hypertension.
* Initial hypertension, or without taking any antihypertensive for at least one month.
* Sexual active.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: 48 weeks
measure: International Index of Erectile Function(IIEF)
timeFrame: 48 weeks
Secondary outcomes:
measure: Change of Systolic Blood Pressure in 2 Weeks
timeFrame: 2 weeks
measure: Change of Systolic Blood Pressure in 4 Weeks
timeFrame: 4 weeks
measure: Change of Systolic Blood Pressure in 8 Weeks
timeFrame: 8 weeks
measure: Change of Systolic Blood Pressure in 12 Weeks
timeFrame: 12 weeks
measure: Change of Systolic Blood Pressure in 24 Weeks
timeFrame: 24 weeks
measure: Change of Systolic Blood Pressure in 48 Weeks
timeFrame: 48 weeks
measure: Change of Diastolic Blood Pressure in 2 Weeks
timeFrame: 2 weeks
measure: Change of Diastolic Blood Pressure in 4 Weeks
timeFrame: 4 weeks
measure: Change of Diastolic Blood Pressure in 8 Weeks
timeFrame: 8 weeks
measure: Change of Diastolic Blood Pressure in 12 Weeks
timeFrame: 12 weeks
measure: Change of Diastolic Blood Pressure in 24 Weeks
timeFrame: 24 weeks
measure: Change of Diastolic Blood Pressure in 48 Weeks
timeFrame: 48 weeks
measure: Serum Estradiol in 24 Weeks
timeFrame: 24 weeks
measure: Serum Estradiol in 48 Weeks
timeFrame: 48 weeks
measure: Serum Testosterone in 24 Weeks
timeFrame: 24 weeks
measure: Serum Testosterone in 48 Weeks
timeFrame: 48 weeks
measure: Serum MDA in 24 Weeks
timeFrame: 24 weeks
measure: Serum MDA in 48 Weeks
timeFrame: 48 weeks
measure: Serum 8-OHdG in 24 Weeks
timeFrame: 24 weeks
measure: Serum 8-OHdG in 48 Weeks
timeFrame: 48 weeks
measure: Serum HNE in 24 Weeks
timeFrame: 24 weeks
measure: Serum HNE in 48 Weeks
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
Study officials:
affiliation: Lanzhou University Second Hospital
name: Jing Yu, Professor
role: STUDY_CHAIR
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