PharmacokineticsNCT02585999

The Pharmacokinetics of 12 Week Continuous Patch Use

A study testing Xulane Contraceptive Patch in people with Pharmacokinetics, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Xulane Contraceptive Patch
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Medical Center
Boston, Massachusetts, 02118

Other trials in United States

About this study

Read the 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.

Conditions: Pharmacokinetics
Being tested: Xulane Contraceptive Patch
Keywords: Hormonal contraception, hormone pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xulane Contraceptive PatchDevice
Also called Ortho Evra®
Extended use (12 weeks) of contraceptive patch

Study groups in NCT02585999
Study group	Role	What they receive
Xulane	Other	All participants using the Xulane contraceptive patch for 12 continuous weeks Receives: Device: Xulane Contraceptive Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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

Secondary outcomes (1)

NGMN Levels Over 12 Weeks of Continuous Patch Use
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Jun 2016

First posted26 Oct 2015 (estimated)
Study startOct 2015
Primary completionMay 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02585999
Sponsor's protocol ID: H-34252
Status last verified: Apr 2017
First submitted: 20 Oct 2015
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pharmacokinetics trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Pharmacokinetics of 12 Week Continuous Patch Use
ClinicalTrials.gov ID: NCT02585999
Acronym / sponsor ID: H-34252
Conditions: Pharmacokinetics
Keywords: Hormonal contraception, hormone pharmacokinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Boston Medical CenterUniversity, hospital or other
Study start: Oct 2015
Primary completion: May 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 26 Oct 2015 (estimated)
Results: Posted 30 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Xulane	Other	Device: Xulane Contraceptive PatchAll participants using the Xulane contraceptive patch for 12 continuous weeks

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xulane Contraceptive PatchAlso: Ortho Evra®Extended use (12 weeks) of contraceptive patch	Device	Xulane

Primary outcome

Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
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
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2

1 secondary outcome

NGMN Levels Over 12 Weeks of Continuous Patch Use
Time frame: 12 weeks

Results and safety

Results posted to the registry on 30 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xulane	28	26

Primary outcome: Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use

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. Mean (Standard Deviation). Unit: pg/ml

Measure	Xulane n = 28
Week 1 (end)	12.5 (14.2)
Week 2 (end)	14.3 (23.9)
Week 3 (end)	10.9 (13.6)
Week 3.5 (mid-week)	42.9 (46.8)
Week 4 (end)	25.9 (33.7)
Week 5 (end)	34.1 (25.7)
Week 6 (end)	36.7 (34.1)
Week 7 (end)	24.7 (26.5)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the entire course of the study (October 2015 through June 2016).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xulane	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Limitations and caveats (from the sponsor): It is difficult to compare our findings with those of previous studies, as previous studies have used other instrumentation and techniques in analysis of EE2. Serum analysis was also performed after all samples were collected from participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonella Lavelanet, DO, JD principal investigator

Boston Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Xulane Contraceptive Patch in people with Pharmacokinetics, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.