Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

NCT01419392 | Unknown Phase 4 DMC

• 1 other identifier: Ahmed-2004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Miscarriage

Keywords

sildenafil citrate; Doppler Ultrasonography; nitric oxide; total antioxidant capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Sildenafil citrate

EXPERIMENTAL

Drug: Sildenafil citrate

placebo

PLACEBO COMPARATOR

Drug: matching placebo

Interventions

Sildenafil citrate DRUG

25 mg orally, 4 times per day for 21 days

Also known as: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt

Sildenafil citrate

matching placebo DRUG

orally, 4 times per day for 21 days

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Concomitant use of organic nitrites, or nitrates
• Severe hepatic, renal, or cardiovascular impairment
• History of stroke or myocardial infarction
• Patients with retinitis pigmentosa.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Sildenafil Citrate; Tablets

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 18, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

EG (1)