This trial is active, not recruiting.

Condition recurrent miscarriage
Treatments sildenafil citrate, matching placebo
Phase phase 4
Sponsor Ain Shams University
Start date September 2011
End date April 2012
Trial size 80 participants
Trial identifier NCT01419392, Ahmed-2004


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
sildenafil citrate Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt
25 mg orally, 4 times per day for 21 days
(Placebo Comparator)
matching placebo placebo
orally, 4 times per day for 21 days

Primary Outcomes

Uterine arteries blood flow
time frame: 21 days

Secondary Outcomes

Nitric oxide serum level as a marked of oxidative stress
time frame: 21 days
Total antioxidant capacity serum level as a marker of oxidative stress
time frame: 21 days

Eligibility Criteria

Female participants from 18 years up to 35 years old.

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.

Additional Information

Official title Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Ain Shams University.