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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01419392
Other study ID # Ahmed-2004
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received August 17, 2011
Last updated April 14, 2012
Start date September 2011
Est. completion date June 2012

Study information

Verified date April 2012
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether sildenafil citrate is effective in improving uterine artery blood flow and oxidative stress in patients with unexplained recurrent miscarriages


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date June 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Age 18-35 years

- Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses

- Three or more months have elapsed since the last abortion

- Postmenstrual period

- No other therapy allowed during our treatment course

Exclusion Criteria:

- Concomitant use of organic nitrites, or nitrates

- Severe hepatic, renal, or cardiovascular impairment

- History of stroke or myocardial infarction

- Patients with retinitis pigmentosa.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

Drug:
Sildenafil citrate
25 mg orally, 4 times per day for 21 days
matching placebo
orally, 4 times per day for 21 days

Locations

Country Name City State
Egypt Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uterine arteries blood flow Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index 21 days No
Secondary Nitric oxide serum level as a marked of oxidative stress 21 days No
Secondary Total antioxidant capacity serum level as a marker of oxidative stress 21 days No
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