An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE).
| Condition | Intervention | Phase |
|---|---|---|
|
Contraception |
Drug: norelgestromine and ethinyl estradiol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol |
- The primary outcome is efficacy during the treatment period of 6 weeks.
- The other outcomes are safety, cycle control, compliance and subject satisfaction during the treatment period of 6 weeks.
| Enrollment: | 580 |
| Study Start Date: | April 2003 |
| Study Completion Date: | December 2004 |
A multicenter, open label, descriptive study. Five hundred requiring contraception will receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive efficacy will be assessed by the Pearl Index and by life table analysis. To assess satisfaction with the weekly transdermal contraceptive patch, this method will be compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2 contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of NLGM and 20 mcg of EE per day.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adult females who meet the following selection criteria: Have regular menses occuring every 25-35 days
- Acceptable body mass (< 30) and the weight is < 90 kg
- Has completed her last term pregnancy at least 4 months prior to study admission, is not lactating and has at least one normal menstrual period since her last pregnancy and not breast feeding
- Has a sitting blood pressure systolic < 140 mm/Hg and diastolic < 90 mm/Hg.
Exclusion Criteria:
- Has not received a DepoProvera injection or any other depot hormone injection within six months prior to the screening visit
- Has not used / or in current use of barbiturates, antiepileptics, rifampin, griseofulvin, Hypericum perforatum, or other hepatic enzyme-inducing drugs within 30 days prior to the pre-study visit
- Has not a uncontrolled disorder
- No women over the age 35 who smoke.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00307632 History of Changes |
| Other Study ID Numbers: | CR002962 |
| Study First Received: | March 24, 2006 |
| Last Updated: | November 29, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
|
Contraception hormonal patch |
Additional relevant MeSH terms:
|
Contraceptive Agents Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol Polyestradiol phosphate Ethinyl Estradiol Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 21, 2013