Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension

NCT01238705 Phase 4 UNKNOWN

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.

Details

Lead sponsor	LanZhou University
Phase	Phase 4
Status	UNKNOWN
Enrolment	280
Start date	2008-04
Completion	2010-11

Conditions

• Hypertension
• Sexual Dysfunction

Interventions

• Felodipine add Irbesartan
• Felodipine add Metoprolol

Primary outcomes

• Female Sexual Function Index (FSFI) — 48 weeks
  The Female Sexual Function Index (FSFI) is a multidimensional self-report scale for assessing sexual function in women.The FSFI hase been validated in women with various sexual disorders,and in non-dysfunctional controls showing good discriminant validity,internal consistency,and test-retest reliability.
• International Index of Erectile Function(IIEF) — 48 weeks
  The 15-item International Index of Erectile Function (IIEF) was developed to diagnose the presence and severity of erectile dysfunction (ED).

Countries

China