Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

NCT ID: NCT01419392

Last Updated: 2012-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Recurrent Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sildenafil citrate

Group Type EXPERIMENTAL

Sildenafil citrate

Intervention Type DRUG

25 mg orally, 4 times per day for 21 days

placebo

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

orally, 4 times per day for 21 days

Interventions

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Sildenafil citrate

25 mg orally, 4 times per day for 21 days

Intervention Type DRUG

matching placebo

orally, 4 times per day for 21 days

Intervention Type DRUG

Other Intervention Names

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Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Tamer El-Refaie

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ahmed-2004

Identifier Type: -

Identifier Source: org_study_id

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