Trial Outcomes & Findings for Hormones Inflammation and Thrombosis (NCT NCT01875185)

Results Overview

Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Baseline

Results posted on

2018-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Premenopausal Aspirin 81 mg PO daily x 7 days	Postmenopausal Aspirin 81 mg PO daily x 7 days
Overall Study STARTED	52	48
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	52	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Premenopausal Aspirin 81 mg PO daily x 7 days	Postmenopausal Aspirin 81 mg PO daily x 7 days
Overall Study study was terminated	52	48

Baseline Characteristics

Hormones Inflammation and Thrombosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Premenopausal n=52 Participants Aspirin 81 mg PO daily x 7 days	Postmenopausal n=48 Participants Aspirin 81 mg PO daily x 7 days	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	0 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	48 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	48 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants	48 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.

Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days.

Outcome measures

Outcome measures
Measure	Premenopausal n=52 Participants premenopausal Women in the cohort	Postmenopausal n=48 Participants Postmenopausal Women in the cohort
Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine	2495 pg/mg Interval 1775.0 to 3053.0	2299 pg/mg Interval 1724.0 to 2687.0

PRIMARY outcome

Timeframe: baseline to 7 days

Population: Data was only collected at baseline. The study was terminated prior to obtaining study data.

Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Population: Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.

Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin

Outcome measures

Outcome measures
Measure	Premenopausal n=52 Participants premenopausal Women in the cohort	Postmenopausal n=48 Participants Postmenopausal Women in the cohort
Level of UTXB2 in pg/mg Creatinine	2299 pg/mg Interval 1724.0 to 2687.0	2824 pg/mg Interval 2198.0 to 3252.0

SECONDARY outcome

Timeframe: change from baseline to 7 days

Population: No data was collected for this outcome measure, as the study was terminated prematurely

Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin

Outcome measures

Outcome data not reported

Adverse Events

Premenopausal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Postmenopausal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

RhondaLyn McLean

Johns Hopkins University School of Medicine

Phone: (215) 662-4949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place