Pharmacokinetics
Conditions
Keywords
Hormonal contraception, hormone pharmacokinetics
Brief summary
Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The primary objective is to assess the change in serum ethinyl estradiol (EE2) levels over 12 weeks of continuous contraceptive patch use. The secondary objective is assessing the the norelgestromin (NGMN) levels over the 12 weeks of continuous contraceptive patch use.
Detailed description
For women who are seeking alternatives to long-acting contraceptives, the oral contraceptive pill and the contraceptive ring are often prescribed in an extended manner (12 weeks straight). The contraceptive patch, however, is not routinely prescribed in this way. Concerns have been raised that hormone levels, in particular estrogen, are higher among patch users than those who use oral contraception or the vaginal ring and that this may contribute to an increased risk of clot. However, few studies have actually looked at these hormone levels in women with extended use of the contraceptive patch. The investigators plan to enroll eligible women age 18-39 who are willing to use the contraceptive patch continuously for twelve weeks, and can adhere to the study requirements for follow-up. All participants will have weekly serum assessments of ethinyl estradiol and norelgestromin levels. The investigators will enroll 30 women, in anticipation of a 33% attrition rate, with the goal of obtaining completed data on 20 participants. The study duration for an individual participant will be 12 weeks and the duration of the entire study will be one year.
Interventions
DEVICEXulane Contraceptive Patch
Extended use (12 weeks) of contraceptive patch
Sponsors
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to come to the clinic to have blood drawn weekly for 12 weeks, biweekly during weeks 4, 8, and 12, and for 3 days after the final patch is removed for blood draws for a total of 18 blood draws * Willing and able to abstain from using any other hormonal contraceptive method while in the study and for the week prior to starting the study
Exclusion criteria
* Body Mass Index greater than 35 * Personal or Family History of Venothromboembolism * Personal History of Migraines with Aura * Personal History of Migraines without Aura * Tobacco use greater than or equal to 15 cigarettes per day * Current Pregnancy * History of or Current Diagnosis of Cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | 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 | Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NGMN Levels Over 12 Weeks of Continuous Patch Use | 12 weeks | Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN |
Countries
United States
Participant flow
Pre-assignment details
30 participants completed the baseline questionnaire, but 2 withdrew prior to starting the study.
Participants by arm
| Arm | Count |
|---|---|
| Xulane Participants exposed to contraceptive patch, Xulane.
Xulane Contraceptive Patch (generic version of Ortho Evra®\*): Extended use (12 Weeks) of Contraceptive Patch | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Xulane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 1 (end) | 12.5 pg/ml | Standard Deviation 14.2 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 2 (end) | 14.3 pg/ml | Standard Deviation 23.9 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 3 (end) | 10.9 pg/ml | Standard Deviation 13.6 |
| Xulane | 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 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 4 (end) | 25.9 pg/ml | Standard Deviation 33.7 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 5 (end) | 34.1 pg/ml | Standard Deviation 25.7 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 6 (end) | 36.7 pg/ml | Standard Deviation 34.1 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 7 (end) | 24.7 pg/ml | Standard Deviation 26.5 |
| Xulane | 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 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 8 (end) | 32.8 pg/ml | Standard Deviation 30.7 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 9 (end) | 40.7 pg/ml | Standard Deviation 33.7 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 10 (end) | 42.6 pg/ml | Standard Deviation 31.4 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 11 (end) | 41.2 pg/ml | Standard Deviation 34 |
| Xulane | 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 |
| Xulane | Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use | Week 12 (end) | 27 pg/ml | Standard Deviation 27.7 |
| Xulane | 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 |
| Xulane | 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 |
| Xulane | 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
NGMN Levels Over 12 Weeks of Continuous Patch Use
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 8 (end) | 0.789 ng/ml | Standard Deviation 0.517 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 1 (end) | 0.691 ng/ml | Standard Deviation 0.279 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 2 (end) | 0.699 ng/ml | Standard Deviation 0.366 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 3 (end) | 0.674 ng/ml | Standard Deviation 0.275 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 3.5 (mid-week) | 1.09 ng/ml | Standard Deviation 0.436 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 4 (end) | 0.746 ng/ml | Standard Deviation 0.364 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 5 (end) | 0.877 ng/ml | Standard Deviation 0.549 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 6 (end) | 0.913 ng/ml | Standard Deviation 0.463 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 7 (end) | 0.689 ng/ml | Standard Deviation 0.34 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 7.5 (mid-week) | 1.06 ng/ml | Standard Deviation 0.653 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 9 (end) | 0.814 ng/ml | Standard Deviation 0.555 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 10 (end) | 0.837 ng/ml | Standard Deviation 0.548 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 11 (end) | 0.792 ng/ml | Standard Deviation 0.551 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 11.5 (mid-week) | 0.954 ng/ml | Standard Deviation 0.707 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 12 (end) | 0.593 ng/ml | Standard Deviation 0.491 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 12.1 (day 1 post patch) | 0.422 ng/ml | Standard Deviation 0.513 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 12.2 (day 2 post patch) | 0.221 ng/ml | Standard Deviation 0.292 |
| Xulane | NGMN Levels Over 12 Weeks of Continuous Patch Use | Week 12.3 (day 3 post patch) | 0.163 ng/ml | Standard Deviation 0.288 |