Recurrent MiscarriagePhase 4NCT01419392
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages
A Phase 4 study testing Sildenafil citrate in people with Recurrent Miscarriage, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- What is being tested?
- Sildenafil citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2011to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Concomitant use of organic nitrites, or nitrates
- Severe hepatic, renal, or cardiovascular impairment
- History of stroke or myocardial infarction
- Patients with retinitis pigmentosa.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department
Cairo, Cairo Governorate
About this study
Official title: 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
- Conditions
- Recurrent Miscarriage
- Being tested
- Sildenafil citrate, matching placebo
- Keywords
- sildenafil citrate, Doppler Ultrasonography, nitric oxide, total antioxidant capacity
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrateDrug
Also called Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt
25 mg orally, 4 times per day for 21 days
matching placeboDrug
Also called placebo
orally, 4 times per day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil citrate | Experimental | Not described Receives: Drug: Sildenafil citrate |
| placebo | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine arteries blood flow
Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index
Measured: 21 days
Secondary outcomes (2)
Nitric oxide serum level as a marked of oxidative stress
Measured: 21 days
Total antioxidant capacity serum level as a marker of oxidative stress
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer El-Refaie, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419392
- Sponsor's protocol ID
- Ahmed-2004
- Status last verified
- Apr 2012
- First submitted
- 17 Aug 2011
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01419392
- Acronym / sponsor ID
- Ahmed-2004
- Conditions
- Recurrent Miscarriage
- Keywords
- sildenafil citrate, Doppler Ultrasonography, nitric oxide, total antioxidant capacity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (estimated)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil citrate | Experimental | Drug: Sildenafil citrate |
| placebo | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Concomitant use of organic nitrites, or nitrates
- Severe hepatic, renal, or cardiovascular impairment
- History of stroke or myocardial infarction
- Patients with retinitis pigmentosa.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil citrateAlso: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt25 mg orally, 4 times per day for 21 days | Drug | Sildenafil citrate |
| matching placeboAlso: placeboorally, 4 times per day for 21 days | Drug | placebo |
Primary outcome
Uterine arteries blood flow
Time frame: 21 days
Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index
2 secondary outcomes
Nitric oxide serum level as a marked of oxidative stress
Time frame: 21 days
Total antioxidant capacity serum level as a marker of oxidative stress
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil citrate in people with Recurrent Miscarriage, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine arteries blood flow (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2012.