Cerebral AneurysmPhase 2EPPANCT01895881
Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial
A Phase 2 study testing Estradiol in people with Cerebral Aneurysm and Menopause, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms. Read more about this study
- Who is it for?
- Ages 40 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cerebral Aneurysm, Menopause, Treatment
- What is being tested?
- Estradiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2018
- Phase
- Phase 2
- 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 40 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy women, 40-52 years of age.
- At least one documented saccular intracranial cerebral aneurysm detected via catheter angiography, magnetic resonance angiography or computed tomography angiography.
- Clinical diagnosis of perimenopause, defined as regular or irregular menses with or without vasomotor symptoms.
Who cannot join
- Known or suspected estrogen-dependent neoplasia.
- Endometrial proliferation, hyperplasia, or malignancy at screening.
- Known hypersensitivity to estrogens, progestins.
- History of myocardial infarction, ischemic heart disease, lipid disorder, or congestive heart failure.
- Known or suspected pregnancy, or recent breast feeding (within 6 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Estrogen Therapy as Prevention in the Progression of Aneurysm
This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.
Read the detailed description
This is a prospective, randomized, placebo-control trial to test the effect of estradiol in the prevention of progression of cerebral aneurysms. To evaluate the effect, each subject will be treated with either oral estradiol or placebo for 6 months. Subjects will be randomly assigned to 1 of 2 groups as follows:
Double Blind Treatment Group Open-Label Regimen A1 1 mg Estradiol daily for 180 days B1 Placebo for 180 days
Each group will be given oral Progesterone (3300 mg) for 10 days at the end of 90 days regardless of menstrual pattern. Subjects will be asked to keep a menstrual calendar throughout the trial. Serum markers will be drawn at baseline and every 90 days with the results blinded until the end of the trial. Magnetic resonance angiography (MRA) studies of the brain will be performed at month 6.
- Conditions
- Cerebral Aneurysm, Menopause, Treatment
- Being tested
- Estradiol, Placebo
- Keywords
- Intracranial Aneurysm, Estradiol
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Estradiol Daily | Experimental | 1 mg Estradiol daily for 180 days. Receives: Drug: Estradiol |
| Placebo | Placebo comparator | Placebo for 180 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of low dose estradiol on a panel of serum markers.
Parallel design double-blind placebo controlled trial to assess the effect of low dose estradiol on serum lipoprotein (a), serum elastase, and homocysteine.
Measured: Change in levels of serum markers from baseline and six months.
Secondary outcomes (1)
Radiographic change in the cerebral vasculature after treatment.
Measured: From date of randomization to six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Unable to Recruit Participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chen, M.D., Rush University Medical Center
- Investigators
- Michael Chen, MD, Principal investigator, Rush University Medical CenterBarbara Soltes, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895881
- Sponsor's protocol ID
- EPPA - 12101906
- Acronym
- EPPA
- Status last verified
- Dec 2020
- First submitted
- 24 May 2013
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chen M, Ouyang B, Goldstein-Smith L, Feldman L. Oral contraceptive and hormone replacement therapy in women with cerebral aneurysms. J Neurointerv Surg. 2011 Jun;3(2):163-6. doi: 10.1136/jnis.2010.003855. Epub 2010 Dec 17.
PubMed 21990811Ding C, Toll V, Ouyang B, Chen M. Younger age of menopause in women with cerebral aneurysms. J Neurointerv Surg. 2013 Jul;5(4):327-31. doi: 10.1136/neurintsurg-2012-010364. Epub 2012 Jun 13.
PubMed 22700728
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Therapy as Prevention in the Progression of Aneurysm
- ClinicalTrials.gov ID
- NCT01895881
- Acronym / sponsor ID
- EPPA / EPPA - 12101906
- Conditions
- Cerebral Aneurysm, Menopause, Treatment
- Keywords
- Intracranial Aneurysm, Estradiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to Recruit Participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Jul 2013 (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.
This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.
Detailed description
This is a prospective, randomized, placebo-control trial to test the effect of estradiol in the prevention of progression of cerebral aneurysms. To evaluate the effect, each subject will be treated with either oral estradiol or placebo for 6 months. Subjects will be randomly assigned to 1 of 2 groups as follows:
Double Blind Treatment Group Open-Label Regimen A1 1 mg Estradiol daily for 180 days B1 Placebo for 180 days
Each group will be given oral Progesterone (3300 mg) for 10 days at the end of 90 days regardless of menstrual pattern. Subjects will be asked to keep a menstrual calendar throughout the trial. Serum markers will be drawn at baseline and every 90 days with the results blinded until the end of the trial. Magnetic resonance angiography (MRA) studies of the brain will be performed at month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol Daily | Experimental | Drug: Estradiol1 mg Estradiol daily for 180 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 180 days. |
Who may qualify
- Ages
- 40 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy women, 40-52 years of age.
- At least one documented saccular intracranial cerebral aneurysm detected via catheter angiography, magnetic resonance angiography or computed tomography angiography.
- Clinical diagnosis of perimenopause, defined as regular or irregular menses with or without vasomotor symptoms.
Key exclusion criteria (5 listed)
- Known or suspected estrogen-dependent neoplasia.
- Endometrial proliferation, hyperplasia, or malignancy at screening.
- Known hypersensitivity to estrogens, progestins.
- History of myocardial infarction, ischemic heart disease, lipid disorder, or congestive heart failure.
- Known or suspected pregnancy, or recent breast feeding (within 6 months).
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 |
|---|---|---|
| Estradiol | Drug | Estradiol Daily |
| Placebo | Drug | Placebo |
Primary outcome
Effect of low dose estradiol on a panel of serum markers.
Time frame: Change in levels of serum markers from baseline and six months.
Parallel design double-blind placebo controlled trial to assess the effect of low dose estradiol on serum lipoprotein (a), serum elastase, and homocysteine.
1 secondary outcome
Radiographic change in the cerebral vasculature after treatment.
Time frame: From date of randomization to six months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Results publication: PubMed 21990811Chen M, Ouyang B, Goldstein-Smith L, Feldman L. Oral contraceptive and hormone replacement therapy in women with cerebral aneurysms. J Neurointerv Surg. 2011 Jun;3(2):163-6. doi: 10.1136/jnis.2010.003855. Epub 2010 Dec 17.
- Results publication: PubMed 22700728Ding C, Toll V, Ouyang B, Chen M. Younger age of menopause in women with cerebral aneurysms. J Neurointerv Surg. 2013 Jul;5(4):327-31. doi: 10.1136/neurintsurg-2012-010364. Epub 2012 Jun 13.
- Individual participant dataSharing planned: Undecided
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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.
Michael Chen, MD principal investigator
Rush University Medical Center
Barbara Soltes, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estradiol in people with Cerebral Aneurysm and Menopause, run by Rush University Medical 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 5 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: withdrawn, as of the sponsor's last update on 5 Jan 2021. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect of low dose estradiol on a panel of serum markers. (time frame: Change in levels of serum markers from baseline and six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01895881, which also lists 2 linked publications.
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 5 Jan 2021.