HealthyPhase 1NCT04017195

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

A Phase 1 study testing EVRA patch (NGMN+EE) (Treatment A) (Reference) and High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test) in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in 3 countries.

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

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: EVRA patch (NGMN+EE) (Treatment A) (Reference) and High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 3 sitesin 3 countries
Study dates: 12 Jul 2019to 13 Dec 2019
Phase: Phase 1
Are there results?: None posted in the registry

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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Participant has a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and body weight not less than 50 kilogram (kg) and not more than 100 kg at screening
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

Who cannot join

Participant has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
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

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Belgium1 site

SGS Belgium NV
Antwerp, 2060

Other trials in Belgium

Germany1 site

Charite - Universitaetsmedizin Berlin (CCM)
Berlin, 10117

Other trials in Germany

Netherlands1 site

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components at the End of Shelf Life and Currently Marketed EVRA® at the Beginning of Shelf Life in Healthy Adult Women

The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component and show non-inferior adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component.

Conditions: Healthy
Being tested: EVRA patch (NGMN+EE) (Treatment A) (Reference), High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

What participants receive

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

EVRA patch (NGMN+EE) (Treatment A) (Reference)Drug
Also called RWJ10553
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)Drug
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.

Study groups in NCT04017195
Study group	Role	What they receive
Group 1: Sequence AB (Right/Left)	Experimental	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. Receives: Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference); Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
Group 2: Sequence BA (Right/Left)	Experimental	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. Receives: Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference); Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
Group 3: Sequence AB (Left/Right)	Experimental	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. Receives: Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference); Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
Group 4: Sequence BA (Left/Right)	Experimental	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. Receives: Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference); Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)

What is being measured

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

Mean Steady-State Concentration (Css) of Norelgestromin (NGMN)
Css is the mean steady-state concentration for NGMN after patch application, will be calculated, as the mean concentration between 48 hours and 168 hours, inclusive, after patch application.
Measured: 48 to 168 hours post-dose
Mean Steady-State Concentration (Css) of Ethinyl Estradiol (EE)
Css is the mean steady-state concentration for EE after patch application, will be calculated, as the mean concentration between 48 hours and 168 hours, inclusive, after patch application.
Measured: 48 to 168 hours post-dose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of NGMN
Tmax is the time to reach the maximum observed plasma concentration of NGMN will be assessed.
Measured: Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of EE
Tmax is the time to reach the maximum observed plasma concentration of EE will be assessed.
Measured: Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
Area Under the Plasma Concentration-Time Curve from Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of NGMN
AUC(0-168) is the area under the concentration versus time curve from zero (patch application) to 168 hours of NGMN in plasma will be assessed.
Measured: Pre-dose to 168 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of EE
AUC(0-168) is the area under the concentration versus time curve from zero (patch application) to 168 hours of EE in plasma will be assessed.
Measured: Pre-dose to 168 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of NGMN
AUC(0-240) is the area under the concentration versus time curve from zero (patch application) to 240 hours of NGMN in plasma will be assessed.
Measured: Pre-dose to 240 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of EE
AUC(0-240) is defined as area under the concentration versus time curve from zero (patch application) to 240 hours of EE in plasma will be assessed.
Measured: Pre-dose to 240 hours post-dose
Cumulative Adhesion Percentage Ratio
Adhesion of patches will be assessed in accordance with the European Medicines Agency (EMA) 0-5 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (EMA 0-5 [percentage (%)] scoring). Estimated percentages of adhesion and corresponding EMA 0-5 score at each interval will be recorded in each participant's electronic case report form. The scoring system for adhesion of transdermal patches is indicated as follows : 0= greater than (>) 90-100% of the patch area adheres; 1= >80-90% of the patch area adheres; 2= >70-80% of the patch area adheres; 3= >60-70% of the patch area adheres; 4= >50-60% of the patch area adheres; 5= 0-less than or equal to (<=) 50% of the patch area adheres.
Measured: Baseline (Day 1) and every 24 hours after patch application up to patch removal at 168 hours (Day 8)]
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for NGMN
AUC (0-infinity) is the area under the concentration versus time curve from zero (patch application) to infinite time of NGMN in plasma will be assessed.
Measured: Pre-dose to 240 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for EE
AUC (0-infinity) is the area under the concentration versus time curve from zero (patch application) to infinite time of EE in plasma will be assessed.
Measured: Pre-dose to 240 hours post-dose

Secondary outcomes (2)

Percentage of Participants with Specific Application Site Reactions
Percentage of participants with specific application site reactions (including erythema, edema, pustules, papules and itching) will be summarized for each treatment.
Measured: Pre-dose, 168.5, and 192 hours post-dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to 97 Days

Timeline

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

12 Jul 201913 Dec 2019

First posted12 Jul 2019
Study start12 Jul 2019
Primary completion13 Dec 2019
Study completion13 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04017195
Sponsor's protocol ID: CR108645
Other IDs: 2019-001893-27, RWJ10553CON1019, 2019
Status last verified: Apr 2025
First submitted: 10 Jul 2019
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

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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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components at the End of Shelf Life and Currently Marketed EVRA® at the Beginning of Shelf Life in Healthy Adult Women
ClinicalTrials.gov ID: NCT04017195
Acronym / sponsor ID: CR108645
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 12 Jul 2019 (actual)
Primary completion: 13 Dec 2019 (actual)
Study completion: 13 Dec 2019 (actual)
First posted: 12 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group 1: Sequence AB (Right/Left)	Experimental	Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference), Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)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.
Group 2: Sequence BA (Right/Left)	Experimental	Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference), Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)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.
Group 3: Sequence AB (Left/Right)	Experimental	Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference), Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)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.
Group 4: Sequence BA (Left/Right)	Experimental	Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference), Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)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.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participant has a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and body weight not less than 50 kilogram (kg) and not more than 100 kg at screening
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

Key exclusion criteria (5 listed)

Participant has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
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

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
EVRA patch (NGMN+EE) (Treatment A) (Reference)Also: RWJ10553A 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.	Drug	Group 1: Sequence AB (Right/Left), Group 2: Sequence BA (Right/Left), Group 3: Sequence AB (Left/Right), Group 4: Sequence BA (Left/Right)
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.	Drug	Group 1: Sequence AB (Right/Left), Group 2: Sequence BA (Right/Left), Group 3: Sequence AB (Left/Right), Group 4: Sequence BA (Left/Right)

Primary outcome

Mean Steady-State Concentration (Css) of Norelgestromin (NGMN)
Time frame: 48 to 168 hours post-dose
Css is the mean steady-state concentration for NGMN after patch application, will be calculated, as the mean concentration between 48 hours and 168 hours, inclusive, after patch application.
Mean Steady-State Concentration (Css) of Ethinyl Estradiol (EE)
Time frame: 48 to 168 hours post-dose
Css is the mean steady-state concentration for EE after patch application, will be calculated, as the mean concentration between 48 hours and 168 hours, inclusive, after patch application.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of NGMN
Time frame: Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
Tmax is the time to reach the maximum observed plasma concentration of NGMN will be assessed.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of EE
Time frame: Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
Tmax is the time to reach the maximum observed plasma concentration of EE will be assessed.
Area Under the Plasma Concentration-Time Curve from Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of NGMN
Time frame: Pre-dose to 168 hours post-dose
AUC(0-168) is the area under the concentration versus time curve from zero (patch application) to 168 hours of NGMN in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of EE
Time frame: Pre-dose to 168 hours post-dose
AUC(0-168) is the area under the concentration versus time curve from zero (patch application) to 168 hours of EE in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of NGMN
Time frame: Pre-dose to 240 hours post-dose
AUC(0-240) is the area under the concentration versus time curve from zero (patch application) to 240 hours of NGMN in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of EE
Time frame: Pre-dose to 240 hours post-dose
AUC(0-240) is defined as area under the concentration versus time curve from zero (patch application) to 240 hours of EE in plasma will be assessed.
Cumulative Adhesion Percentage Ratio
Time frame: Baseline (Day 1) and every 24 hours after patch application up to patch removal at 168 hours (Day 8)]
Adhesion of patches will be assessed in accordance with the European Medicines Agency (EMA) 0-5 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (EMA 0-5 [percentage (%)] scoring). Estimated percentages of adhesion and corresponding EMA 0-5 score at each interval will be recorded in each participant's electronic case report form. The scoring system for adhesion of transdermal patches is indicated as follows : 0= greater than (>) 90-100% of the patch area adheres; 1= >80-90% of the patch area adheres; 2= >70-80% of the patch area adheres; 3= >60-70% of the patch area adheres; 4= >50-60% of the patch area adheres; 5= 0-less than or equal to (<=) 50% of the patch area adheres.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for NGMN
Time frame: Pre-dose to 240 hours post-dose
AUC (0-infinity) is the area under the concentration versus time curve from zero (patch application) to infinite time of NGMN in plasma will be assessed.
Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for EE
Time frame: Pre-dose to 240 hours post-dose
AUC (0-infinity) is the area under the concentration versus time curve from zero (patch application) to infinite time of EE in plasma will be assessed.

2 secondary outcomes

Percentage of Participants with Specific Application Site Reactions
Time frame: Pre-dose, 168.5, and 192 hours post-dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 97 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

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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.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, Germany, Netherlands. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean Steady-State Concentration (Css) of Norelgestromin (NGMN) (time frame: 48 to 168 hours post-dose). The study lists 11 primary outcomes in all. 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 NCT04017195.

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 27 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.