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Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tamer El-Refaie, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01419392
First received: August 17, 2011
Last updated: April 14, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Recurrent Miscarriage
 Drug: Sildenafil citrate
Drug: matching placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Uterine arteries blood flow [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index


Secondary Outcome Measures:
  • Nitric oxide serum level as a marked of oxidative stress [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Total antioxidant capacity serum level as a marker of oxidative stress [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sildenafil citrate Drug: Sildenafil citrate
25 mg orally, 4 times per day for 21 days
Other Name: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt
Placebo Comparator: placebo Drug: matching placebo
orally, 4 times per day for 21 days
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419392

Locations
Egypt
Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
  More Information

No publications provided

Responsible Party: Tamer El-Refaie, Lecturer of Obstetrics and Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT01419392     History of Changes
Other Study ID Numbers: Ahmed-2004
Study First Received: August 17, 2011
Last Updated: April 14, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
sildenafil citrate
Doppler Ultrasonography
nitric oxide
total antioxidant capacity

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013