PK Patch 12 Week Continuous Use
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 39 |
| Updated: | 6/15/2016 |
| Start Date: | October 2015 |
| End Date: | July 2016 |
The Pharmacokinetics of 12 Week Continuous Patch Use
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. Additional objectives include assessing the EE2
area under the curve (AUC) during the study time period, as well as Norelgestromin (NGMN)
levels and NGMN AUC over the 12 weeks of continuous contraceptive patch use.
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. Additional objectives include assessing the EE2
area under the curve (AUC) during the study time period, as well as Norelgestromin (NGMN)
levels and NGMN AUC over the 12 weeks of continuous contraceptive patch use.
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. The investigators will enroll 25 women, in anticipation of a 20% 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.
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. The investigators will enroll 25 women, in anticipation of a 20% 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.
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
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