A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women
NCT ID: NCT04017195
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
68 participants
INTERVENTIONAL
2019-07-12
2019-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Group 1: Sequence AB (Right/Left)
A single patch of currently marketed EVRA patch using the adhesive component at the beginning of shelf life (BOSL) (Treatment A) will be applied to the right buttock of participants on Day 1 of Treatment Period 1, followed by application of a single patch of transdermal contraceptive using newly sourced adhesive component HMW PIB at the end of shelf life (EOSL) (Treatment B) to left buttock of participants on Day 1 of Treatment Period 2. The Treatment periods will be separated by a washout period of 21 days.
EVRA patch (NGMN+EE) (Treatment A) (Reference)
A single transdermal contraceptive patch of EVRA (NGMN + EE) will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
A single transdermal contraceptive HMW PIB (NGMN + EE) patch will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
Group 2: Sequence BA (Right/Left)
Treatment B will be applied to the right buttock of participants on Day 1 in Period 1, followed by Treatment A to the left buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.
EVRA patch (NGMN+EE) (Treatment A) (Reference)
A single transdermal contraceptive patch of EVRA (NGMN + EE) will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
A single transdermal contraceptive HMW PIB (NGMN + EE) patch will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
Group 3: Sequence AB (Left/Right)
Treatment A will be applied to the left buttock of participants on Day 1 in Period 1, followed by Treatment B to the right buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.
EVRA patch (NGMN+EE) (Treatment A) (Reference)
A single transdermal contraceptive patch of EVRA (NGMN + EE) will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
A single transdermal contraceptive HMW PIB (NGMN + EE) patch will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
Group 4: Sequence BA (Left/Right)
Treatment B will be applied to the left buttock of participants on Day 1 in Period 1, followed by Treatment A to the right buttock on Day 1 in Period 2. The Treatment periods will be separated by a washout period of 21 days.
EVRA patch (NGMN+EE) (Treatment A) (Reference)
A single transdermal contraceptive patch of EVRA (NGMN + EE) will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
A single transdermal contraceptive HMW PIB (NGMN + EE) patch will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
Interventions
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EVRA patch (NGMN+EE) (Treatment A) (Reference)
A single transdermal contraceptive patch of EVRA (NGMN + EE) will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
A single transdermal contraceptive HMW PIB (NGMN + EE) patch will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing a highly effective method (that is, failure rate of less than \[\<\] 1 percent \[%\] per year) of non hormonal contraception (example, intrauterine device \[IUD\], male partner sterilization) before admission and throughout the study
* Participant has a blood pressure (after the participant is supine or sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
* Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: Normal sinus rhythm with heart rate between 45 and 100 beats per minute (bpm), extremes included; QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) =\<470 millisecond (ms); QRS interval =\<120 ms; PR interval =\<220 ms. ECG morphology consistent with healthy cardiac conduction and function. Any evidence of heart block and left or right bundle branch block is exclusionary
* Participant must be a non-smoker, ex-smoker for greater than (\>) 6 months, must not use nicotine containing substances including tobacco products (example, cigarettes, e-cigarettes. cigars, chewing tobacco, gum, patch), or tests negative for cotinine at screening and on Day 1 of each treatment period
Exclusion Criteria
* Participant has abnormal thyroid stimulating hormone level at screening
* Participant has evidence of cervical dysplasia as documented by a CytoRich test or Papanicolaou (PAP) smear test within 10 months before screening. If a PAP smear has been done within 10 months prior to screening and results are available (documentation is available at the study site) a cervical smear does not need to be performed
* Participant has used oral hormonal contraception, that is, contraceptive pills, within 3 months before admission to the study site on Day -1 of Treatment Period 1
* Participant currently has a contraceptive implant such as Implanon or Norplant in place, or has had removal of contraceptive implant within the 3 months before admission to the study site on Day -1 of Treatment Period 1
18 Years
45 Years
FEMALE
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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SGS Belgium NV
Antwerp, , Belgium
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, , Germany
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, , Netherlands
Countries
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Other Identifiers
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2019-001893-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RWJ10553CON1019
Identifier Type: OTHER
Identifier Source: secondary_id
CR108645
Identifier Type: -
Identifier Source: org_study_id
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