Trial Outcomes & Findings for Study Of Lybrel In Relation To Venous Thromboembolism (NCT NCT01297348)
NCT ID: NCT01297348
Last Updated: 2013-07-17
Results Overview
Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.
Recruitment status
COMPLETED
Target enrollment
598682 participants
Primary outcome timeframe
Index date (date of VTE diagnosis for case and corresponding date for matched control)
Results posted on
2013-07-17
Participant Flow
Participant milestones
| Measure |
Lybrel
Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
|
Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)
Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
|
|---|---|---|
|
Overall Study
STARTED
|
12281
|
586401
|
|
Overall Study
COMPLETED
|
12281
|
586401
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Of Lybrel In Relation To Venous Thromboembolism
Baseline characteristics by cohort
| Measure |
Lybrel
n=12281 Participants
Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
|
Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)
n=586401 Participants
Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
|
Total
n=598682 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15 to 19 years
|
1549 participants
n=5 Participants
|
151591 participants
n=7 Participants
|
153140 participants
n=5 Participants
|
|
Age, Customized
20 to 24 years
|
1785 participants
n=5 Participants
|
128757 participants
n=7 Participants
|
130542 participants
n=5 Participants
|
|
Age, Customized
25 to 29 years
|
1925 participants
n=5 Participants
|
99632 participants
n=7 Participants
|
101557 participants
n=5 Participants
|
|
Age, Customized
30 to 34 years
|
2079 participants
n=5 Participants
|
79184 participants
n=7 Participants
|
81263 participants
n=5 Participants
|
|
Age, Customized
35 to 39 years
|
2074 participants
n=5 Participants
|
56674 participants
n=7 Participants
|
58748 participants
n=5 Participants
|
|
Age, Customized
40 to 44 years
|
1668 participants
n=5 Participants
|
41299 participants
n=7 Participants
|
42967 participants
n=5 Participants
|
|
Age, Customized
45 to 49 years
|
1201 participants
n=5 Participants
|
29264 participants
n=7 Participants
|
30465 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12281 Participants
n=5 Participants
|
586401 Participants
n=7 Participants
|
598682 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Percentage of Participants With Duration in Health Plan Before First Study OC Prescription
6 to 12 months
|
27.6 percentage of participants
n=5 Participants
|
24.0 percentage of participants
n=7 Participants
|
51.6 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Duration in Health Plan Before First Study OC Prescription
12 to 24 months
|
39.1 percentage of participants
n=5 Participants
|
31.9 percentage of participants
n=7 Participants
|
71.0 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Duration in Health Plan Before First Study OC Prescription
24 to 60 months
|
27.5 percentage of participants
n=5 Participants
|
37.0 percentage of participants
n=7 Participants
|
64.5 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Duration in Health Plan Before First Study OC Prescription
More than 60 months
|
5.8 percentage of participants
n=5 Participants
|
7.1 percentage of participants
n=7 Participants
|
12.9 percentage of participants
n=5 Participants
|
|
Percentage of Obese Participants
|
3.7 percentage of participants
n=5 Participants
|
3.0 percentage of participants
n=7 Participants
|
6.7 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Gynecological Disorders
Endometriosis
|
6.3 percentage of participants
n=5 Participants
|
1.1 percentage of participants
n=7 Participants
|
7.4 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Gynecological Disorders
Menstrual disorder
|
26.8 percentage of participants
n=5 Participants
|
24.8 percentage of participants
n=7 Participants
|
51.6 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Gynecological Disorders
Uterine leiomyoma
|
0.1 percentage of participants
n=5 Participants
|
0.0 percentage of participants
n=7 Participants
|
0.1 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Back Pain
|
11.0 percentage of participants
n=5 Participants
|
8.5 percentage of participants
n=7 Participants
|
19.5 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Cardiovascular Disease
|
3.3 percentage of participants
n=5 Participants
|
2.8 percentage of participants
n=7 Participants
|
6.1 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Hypertension
|
6.3 percentage of participants
n=5 Participants
|
3.7 percentage of participants
n=7 Participants
|
10.0 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Hyperlipidemia
|
8.9 percentage of participants
n=5 Participants
|
5.5 percentage of participants
n=7 Participants
|
14.4 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Diabetes
|
2.2 percentage of participants
n=5 Participants
|
1.7 percentage of participants
n=7 Participants
|
3.9 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Asthma
|
6.9 percentage of participants
n=5 Participants
|
6.8 percentage of participants
n=7 Participants
|
13.7 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Thyroid Disease
|
0.8 percentage of participants
n=5 Participants
|
0.8 percentage of participants
n=7 Participants
|
1.6 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Length of Stay in Health Plan
Less than 1 year
|
3.7 percentage of participants
n=5 Participants
|
4.4 percentage of participants
n=7 Participants
|
8.1 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Length of Stay in Health Plan
1 to 2 years
|
14.6 percentage of participants
n=5 Participants
|
16.8 percentage of participants
n=7 Participants
|
31.4 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Length of Stay in Health Plan
3 to 4 years
|
41.8 percentage of participants
n=5 Participants
|
41.6 percentage of participants
n=7 Participants
|
83.3 percentage of participants
n=5 Participants
|
|
Percentage of Participants With Length of Stay in Health Plan
Greater than or equal to 5 years
|
40.0 percentage of participants
n=5 Participants
|
37.2 percentage of participants
n=7 Participants
|
77.2 percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Index date (date of VTE diagnosis for case and corresponding date for matched control)Population: Analysis population included all enrolled participants who met the eligibility criteria.
Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.
Outcome measures
| Measure |
Lybrel
n=12281 Participants
Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
|
Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)
n=586401 Participants
Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
|
Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)
n=142860 Participants
A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
|
|---|---|---|---|
|
Incidence Rate of Idiopathic Venous Thromboembolism (VTE)
Current users
|
176.2 incidence rate per 100000 person-years
|
87.5 incidence rate per 100000 person-years
|
50.5 incidence rate per 100000 person-years
|
|
Incidence Rate of Idiopathic Venous Thromboembolism (VTE)
Past users
|
54.1 incidence rate per 100000 person-years
|
18.0 incidence rate per 100000 person-years
|
17.6 incidence rate per 100000 person-years
|
PRIMARY outcome
Timeframe: Index date (date of VTE diagnosis for case and corresponding date for matched control)Population: Analysis population included all enrolled participants who met the eligibility criteria.
Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.
Outcome measures
| Measure |
Lybrel
n=12281 Participants
Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
|
Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)
n=586401 Participants
Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
|
Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)
n=142860 Participants
A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
|
|---|---|---|---|
|
Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls
Current user: Case
|
17 participants
|
276 participants
|
53 participants
|
|
Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls
Current user: Matched Control
|
47 participants
|
1144 participants
|
254 participants
|
|
Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls
Past user: Case
|
1 participants
|
14 participants
|
4 participants
|
|
Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls
Past user: Matched Control
|
1 participants
|
39 participants
|
10 participants
|
Adverse Events
Lybrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)
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
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER