Study Stopped
Lack of funds for specimen management and data analysis
Hormones Inflammation and Thrombosis
HIT2
1 other identifier
interventional
100
1 country
1
Brief Summary
The investigators are attempting to determine if the response to aspirin in women is related to the level of estrogen and progesterone that a woman has.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
May 7, 2018
CompletedMay 7, 2018
April 1, 2018
11 months
June 7, 2013
August 15, 2017
April 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine
Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days.
Baseline
The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone
Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days.
baseline to 7 days
Secondary Outcomes (2)
Level of UTXB2 in pg/mg Creatinine
baseline
Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin
change from baseline to 7 days
Study Arms (1)
Aspirin
EXPERIMENTALThe patients are given aspirin 81 mg orally for 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- Women age 18-80
- Signed informed consent.
You may not qualify if:
- History of CAD, Cerebrovascular Accident (CVA) or Peripheral Artery Disease (PAD),
- On chronic aspirin therapy,
- On chronic NSAID therapy.
- Chronic anticoagulation with coumadin,
- Known thrombocytopenia (Platelet count \< 100,000),
- Pregnancy (self-report),
- Currently on any type of contraceptive or hormone replacement therapy,
- Hysterectomy and/or oophorectomy.
- Recent GI bleeding
- Bleeding diathesis
- Chronic Systemic Infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- RhondaLyn McLean
- Organization
- Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Rhondalyn McLean, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 11, 2013
Study Start
December 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
May 7, 2018
Results First Posted
May 7, 2018
Record last verified: 2018-04