An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00653016 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : March 26, 2010
|
Sponsor:
Janssen-Ortho Inc., Canada
Information provided by:
Janssen-Ortho Inc., Canada
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | April 1, 2008 | |||
First Posted Date ICMJE | April 4, 2008 | |||
Last Update Posted Date | March 26, 2010 | |||
Study Start Date ICMJE | October 2002 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
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 | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method | |||
Official Title ICMJE | An Open Label Multicentre Study to Evaluate Patient Satisfaction and Preference for the EVRA Transdermal Contraceptive System Compared to Previously Used Contraceptive Method. | |||
Brief 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. | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Female Contraception | |||
Intervention ICMJE | Drug: norelgestromin; ethinyl estradiol | |||
Study Arms ICMJE | Not Provided | |||
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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
405 | |||
Original Estimated Enrollment ICMJE |
400 | |||
Actual Study Completion Date ICMJE | August 2003 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00653016 | |||
Other Study ID Numbers ICMJE | CR002908 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Janssen-Ortho Inc., Canada | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Janssen-Ortho Inc., Canada | |||
Verification Date | March 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |