The Pharmacokinetics of 12 Week Continuous Patch Use

Completed · Not applicable

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT02585999

Run by

Boston Medical Center

People needed

30

Starts

2015-10-01

Expected to finish

2016-06-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.