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Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Tamer El-Refaie, Ain Shams University.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Tamer El-Refaie, Ain Shams University Identifier:
First received: August 17, 2011
Last updated: April 14, 2012
Last verified: April 2012
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

Condition Intervention Phase
Recurrent Miscarriage Drug: Sildenafil citrate Drug: matching placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial

Resource links provided by NLM:

Further study details as provided by Tamer El-Refaie, Ain Shams University:

Primary Outcome Measures:
  • Uterine arteries blood flow [ Time Frame: 21 days ]
    Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sildenafil citrate Drug: Sildenafil citrate
25 mg orally, 4 times per day for 21 days
Other Name: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt
Placebo Comparator: placebo Drug: matching placebo
orally, 4 times per day for 21 days
Other Name: placebo


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01419392

Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
  More Information

Responsible Party: Tamer El-Refaie, Lecturer of Obstetrics and Gynecology, Ain Shams University Identifier: NCT01419392     History of Changes
Other Study ID Numbers: Ahmed-2004
Study First Received: August 17, 2011
Last Updated: April 14, 2012

Keywords provided by Tamer El-Refaie, Ain Shams University:
sildenafil citrate
Doppler Ultrasonography
nitric oxide
total antioxidant capacity

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Citric Acid
Sildenafil Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents processed this record on September 21, 2017