ContraceptionPhase 4NCT00261482
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
A Phase 4 study testing norelgestromin + ethinyl estradiol in people with Contraception and Female Contraception, run by Janssen Pharmaceutica N.V., Belgium.
Trial summary
The purpose of the study is to evaluate user experience with the EVRA® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRA® Patch, and if applicable, user preference of the EVRA® Patch compared with the previous method of contraception. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Female Contraception
- What is being tested?
- norelgestromin + ethinyl estradiol
- How many people
- 778 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Dec 2004
- Phase
- Phase 4
- 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
- Regular menstrual cycles
- sexually active and at risk of pregnancy
- nonpregnant
- normal Pap smear
Who cannot join
- Presently have or at risk of venous thrombosis or arterial thrombosis
- migraines with focal aura
- severe hypertension
- diabetes mellitus
- hereditary dyslipoproteinemia
- carcinoma of breast, endometrium or other estrogen-dependent neoplasia
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- substance abuse
- skin conditions
- concurrent use of hormone-containing medication
- smoking women over 35 years of age.
About this study
Official title: An Open Label, Multicentre Study of the EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch in Europe: Evaluation of Women's Experience With EVRA� and Comparison With Previously Used Methods of Contraception.
The purpose of the study is to evaluate user experience with the EVRA® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRA® Patch, and if applicable, user preference of the EVRA® Patch compared with the previous method of contraception. The study also evaluates contraceptive efficacy, safety and user compliance.
Read the detailed description
EVRA is the first transdermal contraceptive patch to receive approval by Health Canada and Marketing Authorization throughout the European Union. This is an open-label, single-arm, multicenter clinical study with a treatment duration of 24 weeks (6 treatment cycles of 4 weeks). Four clinic visits are scheduled: a screening Visit 1, in which subjects are asked to complete a set of questions about satisfaction with the current method of contraception, and questions about overall health status. Visits 2, 3, and 4 follow after Cycles 1, 3, and 6, respectively of EVRA treatment. At Visits 3 and 4, the subjects are asked to answer questions about satisfaction with EVRA, and about overall health status. At Visit 4 (final study visit) the subjects are asked to compare EVRA with previously used contraceptive methods. Compliance is assessed at all visits by returned boxes of study medication and a review of Diary Cards where subjects recorded the dates and sites of patch application, and details of any patch detachment. The study will generate the first large-scale, European dataset on women's experience with EVRA, including satisfaction, safety, efficacy, and compliance. These data will be compared with subjects' experience with previously used methods of contraception. Each EVRA patch, containing 6 mg NGMN and 600 ug EE, and delivering 150 microgram NGMN and 20 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks. The fourth week is patch-free. Subjects can wear EVRA on 1 of 4 areas: buttock, abdomen, upper torso, or upper arm.
- Conditions
- Contraception, Female Contraception
- Being tested
- norelgestromin + ethinyl estradiol
- Keywords
- contraception, female contraception, hormonal contraception, transdermal contraception, EVRA, estrogen, progestin, ethinyl estradiol, norelgestromin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norelgestromin + ethinyl estradiolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of satisfaction with EVRA after 3 and 6 cycles of use. Comparisons are made between EVRA satisfaction level and that with the previous primary contraceptive method.
Secondary outcomes (1)
Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startJul 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261482
- Sponsor's protocol ID
- CR002905
- Status last verified
- Nov 2010
- First submitted
- 2 Dec 2005
- Last updated
- 16 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicentre Study of the EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch in Europe: Evaluation of Women's Experience With EVRA� and Comparison With Previously Used Methods of Contraception.
- ClinicalTrials.gov ID
- NCT00261482
- Acronym / sponsor ID
- CR002905
- Conditions
- Contraception, Female Contraception
- Keywords
- contraception, female contraception, hormonal contraception, transdermal contraception, EVRA, estrogen, progestin, ethinyl estradiol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Dec 2004 (actual)
- First posted
- 5 Dec 2005 (estimated)
- 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.
The purpose of the study is to evaluate user experience with the EVRA® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRA® Patch, and if applicable, user preference of the EVRA® Patch compared with the previous method of contraception. The study also evaluates contraceptive efficacy, safety and user compliance.
Detailed description
EVRA is the first transdermal contraceptive patch to receive approval by Health Canada and Marketing Authorization throughout the European Union. This is an open-label, single-arm, multicenter clinical study with a treatment duration of 24 weeks (6 treatment cycles of 4 weeks). Four clinic visits are scheduled: a screening Visit 1, in which subjects are asked to complete a set of questions about satisfaction with the current method of contraception, and questions about overall health status. Visits 2, 3, and 4 follow after Cycles 1, 3, and 6, respectively of EVRA treatment. At Visits 3 and 4, the subjects are asked to answer questions about satisfaction with EVRA, and about overall health status. At Visit 4 (final study visit) the subjects are asked to compare EVRA with previously used contraceptive methods. Compliance is assessed at all visits by returned boxes of study medication and a review of Diary Cards where subjects recorded the dates and sites of patch application, and details of any patch detachment. The study will generate the first large-scale, European dataset on women's experience with EVRA, including satisfaction, safety, efficacy, and compliance. These data will be compared with subjects' experience with previously used methods of contraception. Each EVRA patch, containing 6 mg NGMN and 600 ug EE, and delivering 150 microgram NGMN and 20 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks. The fourth week is patch-free. Subjects can wear EVRA on 1 of 4 areas: buttock, abdomen, upper torso, or upper arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Regular menstrual cycles
- sexually active and at risk of pregnancy
- nonpregnant
- normal Pap smear
Key exclusion criteria (10 listed)
- Presently have or at risk of venous thrombosis or arterial thrombosis
- migraines with focal aura
- severe hypertension
- diabetes mellitus
- hereditary dyslipoproteinemia
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 |
|---|---|---|
| norelgestromin + ethinyl estradiol | Drug | – |
Primary outcome
Level of satisfaction with EVRA after 3 and 6 cycles of use. Comparisons are made between EVRA satisfaction level and that with the previous primary contraceptive method.
1 secondary outcome
Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
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 16 Nov 2010.
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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 Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing norelgestromin + ethinyl estradiol in people with Contraception and Female Contraception, run by Janssen Pharmaceutica N.V., Belgium.
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 4 inclusion and 10 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 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Level of satisfaction with EVRA after 3 and 6 cycles of use. Comparisons are made between EVRA satisfaction level and that with the previous primary contraceptive method.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2010.