Trial Outcomes & Findings for The Pharmacokinetics of 12 Week Continuous Patch Use (NCT NCT02585999)
NCT ID: NCT02585999
Last Updated: 2017-05-30
Results Overview
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removed
Results posted on
2017-05-30
Participant Flow
30 participants completed the baseline questionnaire, but 2 withdrew prior to starting the study.
Participant milestones
| Measure |
Xulane
Participants exposed to contraceptive patch, Xulane.
Xulane Contraceptive Patch (generic version of Ortho Evra®\*): Extended use (12 Weeks) of Contraceptive Patch
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Xulane
Participants exposed to contraceptive patch, Xulane.
Xulane Contraceptive Patch (generic version of Ortho Evra®\*): Extended use (12 Weeks) of Contraceptive Patch
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
The Pharmacokinetics of 12 Week Continuous Patch Use
Baseline characteristics by cohort
| Measure |
Xulane
n=28 Participants
Participants exposed to contraceptive patch, Xulane.
Xulane Contraceptive Patch (generic version of Ortho Evra®\*): Extended use (12 Weeks) of Contraceptive Patch
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removedPopulation: Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early \[lost to follow up\]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2
Outcome measures
| Measure |
Xulane
n=28 Participants
Participants exposed to Xulane Contraceptive Patch for 12 weeks of continuous use
|
|---|---|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 1 (end)
|
12.5 pg/ml
Standard Deviation 14.2
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 2 (end)
|
14.3 pg/ml
Standard Deviation 23.9
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 3 (end)
|
10.9 pg/ml
Standard Deviation 13.6
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 3.5 (mid-week)
|
42.9 pg/ml
Standard Deviation 46.8
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 4 (end)
|
25.9 pg/ml
Standard Deviation 33.7
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 5 (end)
|
34.1 pg/ml
Standard Deviation 25.7
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 6 (end)
|
36.7 pg/ml
Standard Deviation 34.1
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 7 (end)
|
24.7 pg/ml
Standard Deviation 26.5
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 7.5 (mid-week)
|
48 pg/ml
Standard Deviation 47.6
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 8 (end)
|
32.8 pg/ml
Standard Deviation 30.7
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 9 (end)
|
40.7 pg/ml
Standard Deviation 33.7
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 10 (end)
|
42.6 pg/ml
Standard Deviation 31.4
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 11 (end)
|
41.2 pg/ml
Standard Deviation 34
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 11.5 (mid-week)
|
47.1 pg/ml
Standard Deviation 35.3
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 12 (end)
|
27 pg/ml
Standard Deviation 27.7
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 12.1 (day 1 post patch)
|
17.8 pg/ml
Standard Deviation 28.7
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 12.2 (day 2 post patch)
|
12 pg/ml
Standard Deviation 17.4
|
|
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Week 12.3 (day 3 post patch)
|
10.4 pg/ml
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early \[lost to follow up\]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN
Outcome measures
| Measure |
Xulane
n=28 Participants
Participants exposed to Xulane Contraceptive Patch for 12 weeks of continuous use
|
|---|---|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 7.5 (mid-week)
|
1.06 ng/ml
Standard Deviation 0.653
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 8 (end)
|
0.789 ng/ml
Standard Deviation 0.517
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 9 (end)
|
0.814 ng/ml
Standard Deviation 0.555
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 10 (end)
|
0.837 ng/ml
Standard Deviation 0.548
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 11 (end)
|
0.792 ng/ml
Standard Deviation 0.551
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 11.5 (mid-week)
|
0.954 ng/ml
Standard Deviation 0.707
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 12 (end)
|
0.593 ng/ml
Standard Deviation 0.491
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 1 (end)
|
0.691 ng/ml
Standard Deviation 0.279
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 2 (end)
|
0.699 ng/ml
Standard Deviation 0.366
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 3 (end)
|
0.674 ng/ml
Standard Deviation 0.275
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 3.5 (mid-week)
|
1.09 ng/ml
Standard Deviation 0.436
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 4 (end)
|
0.746 ng/ml
Standard Deviation 0.364
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 5 (end)
|
0.877 ng/ml
Standard Deviation 0.549
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 6 (end)
|
0.913 ng/ml
Standard Deviation 0.463
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 7 (end)
|
0.689 ng/ml
Standard Deviation 0.340
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 12.1 (day 1 post patch)
|
0.422 ng/ml
Standard Deviation 0.513
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 12.2 (day 2 post patch)
|
0.221 ng/ml
Standard Deviation 0.292
|
|
NGMN Levels Over 12 Weeks of Continuous Patch Use
Week 12.3 (day 3 post patch)
|
0.163 ng/ml
Standard Deviation 0.288
|
Adverse Events
Xulane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xulane
n=28 participants at risk
All participants using the Xulane contraceptive patch for 12 continuous weeks
|
|---|---|
|
General disorders
Any Adverse Event
|
0.00%
0/28 • Adverse event data were collected over the entire course of the study (October 2015 through June 2016).
The at risk numbers represent the 28 participants who were enrolled in the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place