Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

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: Recurrent Miscarriage
• Intervention / Treatment: Drug: matching placebo; Drug: Sildenafil citrate

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	21 days
Total antioxidant capacity serum level as a marker of oxidative stress	21 days

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

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: nitric oxide; Doppler Ultrasonography; sildenafil citrate; total antioxidant capacity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: Ahmed-2004