Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

April 14, 2012 updated by: Tamer El-Refaie, Ain Shams University

Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: matching placebo
orally, 4 times per day for 21 days
Other Names:
  • placebo
Experimental: Sildenafil citrate
Drug: Sildenafil citrate
25 mg orally, 4 times per day for 21 days
Other Names:
  • Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Nitric oxide serum level as a marked of oxidative stress
Time Frame: 21 days
21 days
Total antioxidant capacity serum level as a marker of oxidative stress
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 14, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahmed-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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