An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
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|ClinicalTrials.gov Identifier: NCT00307632|
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : May 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||580 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
|Experimental: Norelgestromine (NLGM)/Ethinyl Estradiol (EE)||
Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)
Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).
- Pregnancy Rate Determined by Pearl Index [ Time Frame: Cycle 6 (Day 168) ]Pearl Index is the number of pregnancies with use of therapy divided by the number of cycles with therapy use. It is an estimation of the number of pregnancies per 100 woman-years of product use.
- Pregnancy Rate Determined by Table of Life Analysis [ Time Frame: Cycle 6 (Day 168) ]Pregnancy rate was determined by table of life analysis.
- Percentage of Participants With Breakthrough Bleeding and/or Spotting [ Time Frame: Day 28 of Cycle 1, 3 and 6 ]Percentage of participants with breakthrough bleeding and/or spotting was reported.
- Compliance Score [ Time Frame: Day 28 of Cycle 1, 2, 3, 4, 5 and 6 ]Score of compliance was calculated for each participant by dividing the number of cycles with at least one day without the study drug by the total number of therapy cycles. Average score was calculated for cycle 1 to 6.
- Percentage of Participants With Response to Satisfaction Questionnaire [ Time Frame: Day 28 of Cycle 1, 3 and 6 ]Percentage of participants with response to satisfaction questionnaire was reported for following categories: previous contraceptive, method election, physical well-being, emotional well-being, intermenstrual bleeding and intensity, menstrual flow volume, pre-menstrual symptoms, and easiness in ethinyl estradiol and norelgestromin transdermal patch use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307632
|Belo Horizonte, Brazil|
|Porto Alegre, Brazil|
|Ribeirao Preto, Brazil|
|Sao Paulo, Brazil|
|Ciudad De Mexico, Mexico|
|Study Director:||Janssen-Cilag Farmaceutica Ltda. Clinical Trial||Janssen-Cilag Farmaceutica Ltda.|