Female ContraceptionPhase 4NCT00653016
An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method
A Phase 4 study testing norelgestromin; ethinyl estradiol in people with Female Contraception, run by Janssen-Ortho Inc., Canada.
Trial summary
The purpose of this study is to document the experience of transdermal contraceptive patch over a period of 9 cycles, compared to their previous contraceptive method. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Female Contraception
- What is being tested?
- norelgestromin; ethinyl estradiol
- How many people
- 405 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Aug 2003
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Healthy females, who were sexually active and at risk of pregnancy were eligible to participate in this study provided that they had regular menses occurring every 25 to 35 days (except for those women using medroxyprogesterone acetate)
- women who were using one of the following methods of contraception as their primary method in the 3 months prior to admission: oral contraceptive, intrauterine device, medroxyprogesterone acetate injection, double-barrier method consisting of condoms and spermicidal foam or gel, or a diaphragm and spermicidal foam or gel
- study participants had to have a normal Pap smear within the previous 12 months
- a negative urine pregnancy test at admission
- have a systolic/diastolic blood pressure <= 140/90 mm Hg
- be within 35% of acceptable body mass index (upper limit of 32.4)
- be willing to switch their current method of contraception
- and agree not to use any other steroid hormonal therapy other than topical corticosteroids or inhaled corticosteroids for asthma, during the course of the study.
Who cannot join
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, e.g., deep vein thrombophlebitis, thromboembolic disorders, cerebral vascular or coronary artery disease, etc.
- Additionally, participants who were menopausal
- had skin conditions resulting in oily, irritated or damaged skin at all potential application sites
- Had a history or presence of dermal hypersensitivity
- The presently used contraceptive method were any of condoms alone, abstinence, withdrawal, or a rhythm method
- Had received medroxyprogesterone acetate injection <=12 weeks prior to enrolment
Show all 14Show fewer
- had a history of alcohol or substance abuse within 12 months of enrolment
- had received any experimental drug or device within 30 days of enrolment
- Had used barbiturates, antiepileptics, rifampin, griseofulvin, or other hepatic enzyme inducing drugs within 30 days of enrolment
- Chronic systemic antibiotic use
- Had an uncontrolled thyroid disorder
- Were smokers over the age of 35
- Had Pap smear evidence of atypical squamous cells or adenocarcinoma or other malignancy
- Had a desire to conceive in the subsequent 9 months of enrolment
About this study
Official title: An Open Label Multicentre Study to Evaluate Patient Satisfaction and Preference for the EVRA Transdermal Contraceptive System Compared to Previously Used Contraceptive Method.
The purpose of this study is to document the experience of transdermal contraceptive patch over a period of 9 cycles, compared to their previous contraceptive method.
Read the detailed description
This was a multicentre, single-arm, open-label study. The objective of this phase IV study was to document the experience of women with the transdermal contraceptive patch (a weekly contraceptive patch delivering 150 mg norelgestromin/20 mg ethinyl estradiol daily) over a period of 9 cycles, compared to their previous contraceptive method. An open-label, multicentre, descriptive cohort study of 392 women requiring contraception were enrolled to receive the patch for nine cycles. A single treatment cycle consisted of three consecutive 7-day patch applications followed by one patch-free week. At the final visit, overall satisfaction and preference for the patch was rated compared to the previous contraceptive method.) The primary outcomes were treatment preference and overall satisfaction. Compliance, contraceptive efficacy, adhesion, and safety measures were secondary outcomes. Study participants were scheduled to receive the contraceptive patch for up to nine consecutive treatment cycles. Participants attended the clinic for 3 study visits: baseline/screening, Day 28 of Cycle 3 and Day 28 of Cycle 9 (or at early termination). A telephone interview was conducted on Day 28 of Cycle 6. Approximately 400 women were to be enrolled into the study and receive the transdermal contraceptive patch. Patients were recruited using ethics approved advertisements, in addition to investigators approaching patients presenting for routine well-woman checks. Participants who met all of the eligibility criteria were instructed to apply the first patch on the first day of their next menses (or 13 weeks following the last medroxyprogesterone acetate injection) and to wear this patch for seven days. They were then instructed to apply a new patch for weeks 2 and 3, and then be patch-free for week 4. Applying a new patch on the day after week 4 ended started a new cycle. All patches were to be applied/changed on the same day of the week and at approximately the same time of day. Only one patch was to be worn at a time. Patches could be applied to the buttocks, abdomen, upper outer arm, or upper torso (excluding breasts) and participants were instructed to apply new patches to a different site. Patches were to adhere on their own; no supplemental tape or adhesive was permitted. If a patch partially detached, participants could reapply it; however, patches that completely detached were to be replaced immediately and the replacement patch would be worn for the remainder of that week. Eligible patients were instructed to apply the 1st patch on the first day of their next menses (or 13 weeks following last medroxyprogesterone acetate injection) and to wear this patch for 7days. They were then instructed to apply a new patch for weeks 2 and 3, and then be patch-free for week 4. Applying a new patch on the day after week 4 ended started a new cycle. All patches were to be applied/changed on the same day of the week and at approximately the same time of day.
- Conditions
- Female Contraception
- Being tested
- norelgestromin; ethinyl estradiol
- Keywords
- Contraception, norelgestromin, ethinyl estradiol, transdermal contraceptive patch, EVRA, ORTHO EVRA
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.
Final visit - preference for patch vs. previous method, identify main reason for preference; satisfaction questionnaire with the previous contraceptive method at baseline and with the patch at the end of cycles 3, 6, 9 or early termination
Secondary outcomes (1)
ongoing compliance based on dosing data recorded in diary cards; efficacy using the Pearl Index; patch adhesion using diary cards; adverse events at each visit, vital signs, body weigh changes, physical and gynaecological exams
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startOct 2002
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female 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
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Ortho Inc., Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Ortho Inc. Clinical Trial, Study director, Janssen-Ortho Inc., Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653016
- Sponsor's protocol ID
- CR002908
- Status last verified
- Mar 2010
- First submitted
- 1 Apr 2008
- Last updated
- 26 Mar 2010
- Results posted
- No
Publications
Weisberg F, Bouchard C, Moreau M, Audet MC, Mawdsley S, Dattani D, Dinniwell J, Horbay GL; NRGEEP-CON-401 Study Group. Preference for and satisfaction of Canadian women with the transdermal contraceptive patch versus previous contraceptive method: an open-label, multicentre study. J Obstet Gynaecol Can. 2005 Apr;27(4):350-9. doi: 10.1016/s1701-2163(16)30462-5.
PubMed 15937609
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multicentre Study to Evaluate Patient Satisfaction and Preference for the EVRA Transdermal Contraceptive System Compared to Previously Used Contraceptive Method.
- ClinicalTrials.gov ID
- NCT00653016
- Acronym / sponsor ID
- CR002908
- Conditions
- Female Contraception
- Keywords
- Contraception, norelgestromin, ethinyl estradiol, transdermal contraceptive patch, EVRA, ORTHO EVRA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Janssen-Ortho Inc., CanadaIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Aug 2003 (actual)
- First posted
- 4 Apr 2008 (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 this study is to document the experience of transdermal contraceptive patch over a period of 9 cycles, compared to their previous contraceptive method.
Detailed description
This was a multicentre, single-arm, open-label study. The objective of this phase IV study was to document the experience of women with the transdermal contraceptive patch (a weekly contraceptive patch delivering 150 mg norelgestromin/20 mg ethinyl estradiol daily) over a period of 9 cycles, compared to their previous contraceptive method. An open-label, multicentre, descriptive cohort study of 392 women requiring contraception were enrolled to receive the patch for nine cycles. A single treatment cycle consisted of three consecutive 7-day patch applications followed by one patch-free week. At the final visit, overall satisfaction and preference for the patch was rated compared to the previous contraceptive method.) The primary outcomes were treatment preference and overall satisfaction. Compliance, contraceptive efficacy, adhesion, and safety measures were secondary outcomes. Study participants were scheduled to receive the contraceptive patch for up to nine consecutive treatment cycles. Participants attended the clinic for 3 study visits: baseline/screening, Day 28 of Cycle 3 and Day 28 of Cycle 9 (or at early termination). A telephone interview was conducted on Day 28 of Cycle 6. Approximately 400 women were to be enrolled into the study and receive the transdermal contraceptive patch. Patients were recruited using ethics approved advertisements, in addition to investigators approaching patients presenting for routine well-woman checks. Participants who met all of the eligibility criteria were instructed to apply the first patch on the first day of their next menses (or 13 weeks following the last medroxyprogesterone acetate injection) and to wear this patch for seven days. They were then instructed to apply a new patch for weeks 2 and 3, and then be patch-free for week 4. Applying a new patch on the day after week 4 ended started a new cycle. All patches were to be applied/changed on the same day of the week and at approximately the same time of day. Only one patch was to be worn at a time. Patches could be applied to the buttocks, abdomen, upper outer arm, or upper torso (excluding breasts) and participants were instructed to apply new patches to a different site. Patches were to adhere on their own; no supplemental tape or adhesive was permitted. If a patch partially detached, participants could reapply it; however, patches that completely detached were to be replaced immediately and the replacement patch would be worn for the remainder of that week. Eligible patients were instructed to apply the 1st patch on the first day of their next menses (or 13 weeks following last medroxyprogesterone acetate injection) and to wear this patch for 7days. They were then instructed to apply a new patch for weeks 2 and 3, and then be patch-free for week 4. Applying a new patch on the day after week 4 ended started a new cycle. All patches were to be applied/changed on the same day of the week and at approximately the same time of day.
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
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy females, who were sexually active and at risk of pregnancy were eligible to participate in this study provided that they had regular menses occurring every 25 to 35 days (except for those women using medroxyprogesterone acetate)
- women who were using one of the following methods of contraception as their primary method in the 3 months prior to admission: oral contraceptive, intrauterine device, medroxyprogesterone acetate injection, double-barrier method consisting of condoms and spermicidal foam or gel, or a diaphragm and spermicidal foam or gel
- study participants had to have a normal Pap smear within the previous 12 months
- a negative urine pregnancy test at admission
- have a systolic/diastolic blood pressure <= 140/90 mm Hg
Key exclusion criteria (14 listed)
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, e.g., deep vein thrombophlebitis, thromboembolic disorders, cerebral vascular or coronary artery disease, etc.
- Additionally, participants who were menopausal
- had skin conditions resulting in oily, irritated or damaged skin at all potential application sites
- Had a history or presence of dermal hypersensitivity
- The presently used contraceptive method were any of condoms alone, abstinence, withdrawal, or a rhythm method
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
Final visit - preference for patch vs. previous method, identify main reason for preference; satisfaction questionnaire with the previous contraceptive method at baseline and with the patch at the end of cycles 3, 6, 9 or early termination
1 secondary outcome
ongoing compliance based on dosing data recorded in diary cards; efficacy using the Pearl Index; patch adhesion using diary cards; adverse events at each visit, vital signs, body weigh changes, physical and gynaecological exams
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 26 Mar 2010.
- Results publication: PubMed 15937609Weisberg F, Bouchard C, Moreau M, Audet MC, Mawdsley S, Dattani D, Dinniwell J, Horbay GL; NRGEEP-CON-401 Study Group. Preference for and satisfaction of Canadian women with the transdermal contraceptive patch versus previous contraceptive method: an open-label, multicentre study. J Obstet Gynaecol Can. 2005 Apr;27(4):350-9. doi: 10.1016/s1701-2163(16)30462-5.
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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-Ortho Inc. Clinical Trial study director
Janssen-Ortho Inc., Canada
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing norelgestromin; ethinyl estradiol in people with Female Contraception, run by Janssen-Ortho Inc., Canada.
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 8 inclusion and 14 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 26 Mar 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?
Final visit - preference for patch vs. previous method, identify main reason for preference; satisfaction questionnaire with the previous contraceptive method at baseline and with the patch at the end of cycles 3, 6, 9 or early termination. 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 NCT00653016, which also lists 1 linked publication.
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 26 Mar 2010.