Role of Sildenafil Citrate in Patients With Unexplained R... | NCT01419392

Studies
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

NCT01419392

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Apr 17, 2012Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

Recurrent Miscarriage

Interventions

Sildenafil citrate
matching placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Jun 2012Estimated

First Submitted Date

Aug 17, 2011

First Submission Date that Met QC Criteria

Aug 17, 2011

First Posted Date

Aug 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2012

Last Update Posted Date

Apr 17, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tamer El-Refaie, Lecturer of Obstetrics and Gynecology, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sildenafil citrate	Experimental		Drug: Sildenafil citrate
placebo	Placebo Comparator		Drug: matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sildenafil citrate	Drug	25 mg orally, 4 times per day for 21 days	Sildenafil citrate

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department		Cairo	Cairo Governorate		Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000026	Abortion, Habitual

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068677	Sildenafil Citrate
D013607	Tablets

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided