- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261482
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
November 15, 2010 updated by: Janssen Pharmaceutica N.V., Belgium
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
778
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Regular menstrual cycles
- sexually active and at risk of pregnancy
- nonpregnant
- normal Pap smear
Exclusion Criteria:
- 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
- substance abuse
- skin conditions
- concurrent use of hormone-containing medication
- smoking women over 35 years of age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
December 2, 2005
First Submitted That Met QC Criteria
December 2, 2005
First Posted (Estimate)
December 5, 2005
Study Record Updates
Last Update Posted (Estimate)
November 16, 2010
Last Update Submitted That Met QC Criteria
November 15, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Estradiol
- Ethinyl Estradiol
- Norelgestromin
Other Study ID Numbers
- CR002905
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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