Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419392
Recruitment Status : Unknown
Verified April 2012 by Tamer El-Refaie, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : August 18, 2011
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):
Tamer El-Refaie, Ain Shams University

Brief 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

Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Drug: Sildenafil citrate Drug: matching placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Nitric oxide serum level as a marked of oxidative stress [ Time Frame: 21 days ]
  2. Total antioxidant capacity serum level as a marker of oxidative stress [ Time Frame: 21 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419392

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

Responsible Party: Tamer El-Refaie, Lecturer of Obstetrics and Gynecology, Ain Shams University Identifier: NCT01419392     History of Changes
Other Study ID Numbers: Ahmed-2004
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 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