vonWillebrand DiseaseNCT00697385
The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
A study testing Cyclokapron in people with vonWillebrand Disease and Hemophilia, run by Mary M. Gooley Hemophilia Center at 1 site in United States.
Trial summary
The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in… Read more about this study
- Who is it for?
- Ages 8 to 60 years, women only
- Conditions the study is for
- vonWillebrand Disease, Hemophilia, Platelet Coagulation Disorders
- What is being tested?
- Cyclokapron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jun 2008
- Phase
- Interventional
- 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 8 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- all menstruating women regardless of age
- Women with heavy periods as measured by pictorial blood assessment chart
- Women diagnosed with a bleeding disorder
Who cannot join
- Acquired defective color vision
- Factor VIII, Factor IX, FactorXI levels >250%
- An inherited thrombophilic defect detected because of a positive family or personal history of thrombosis
- Current use of oral contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary M. Gooley Hemophilia Center
Rochester, New York, 14621
About this study
Official title: Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.
Read the detailed description
Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. Their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. If the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.
- Being tested
- Cyclokapron
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclokapronDrug
Also called tranexamic Acid
(2) 500mg tablets taken by mouth every 6-8 hours
| Study group | Role | What they receive |
|---|---|---|
| TA | Experimental | on treatment Receives: Drug: Cyclokapron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced pictorial blood assessment chart scores from baseline
Measured: 3 and 6 months after start of medication
Secondary outcomes (1)
increased hematocrit
Measured: 3 and 6 months from start of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startApr 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for vonWillebrand DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary M. Gooley Hemophilia Center
- Sponsor type
- University, hospital or other
- Investigators
- Peter A Kouides, MD, Principal investigator, Mary M. Gooley Hemophilia Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697385
- Sponsor's protocol ID
- 758-A-03-1
- Status last verified
- Sep 2008
- First submitted
- 10 Jun 2008
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
- ClinicalTrials.gov ID
- NCT00697385
- Acronym / sponsor ID
- 758-A-03-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mary M. Gooley Hemophilia CenterUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Jun 2008 (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 high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.
Detailed description
Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. Their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. If the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TA | Experimental | Drug: Cyclokapronon treatment |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- all menstruating women regardless of age
- Women with heavy periods as measured by pictorial blood assessment chart
- Women diagnosed with a bleeding disorder
Key exclusion criteria (4 listed)
- Acquired defective color vision
- Factor VIII, Factor IX, FactorXI levels >250%
- An inherited thrombophilic defect detected because of a positive family or personal history of thrombosis
- Current use of oral contraceptives
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 |
|---|---|---|
| CyclokapronAlso: tranexamic Acid(2) 500mg tablets taken by mouth every 6-8 hours | Drug | TA |
Primary outcome
Reduced pictorial blood assessment chart scores from baseline
Time frame: 3 and 6 months after start of medication
1 secondary outcome
increased hematocrit
Time frame: 3 and 6 months from start of medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2008.
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Oxidative Stress, vonWillebrand Disease
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.
Peter A Kouides, MD principal investigator
Mary M. Gooley Hemophilia Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclokapron in people with vonWillebrand Disease and Hemophilia, run by Mary M. Gooley Hemophilia Center at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 19 Sep 2008. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduced pictorial blood assessment chart scores from baseline (time frame: 3 and 6 months after start of medication). 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 19 Sep 2008.