An Open-Label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol - Full Text View

Sponsor:	Janssen-Cilag Farmaceutica Ltda.
Information provided by:	Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier:	NCT00307632

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 IV

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Janssen-Cilag Farmaceutica Ltda.:

Primary Outcome Measures:

The primary outcome is efficacy during the treatment period of 6 weeks.

Secondary Outcome Measures:

The other outcomes are safety, cycle control, compliance and subject satisfaction during the treatment period of 6 weeks.

Estimated Enrollment:	500
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2004

Detailed Description:

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

Criteria

Inclusion Criteria:

Healthy adult females who meet the following selection criteria: Have regular menses occuring every 25-35 days
Aceptable 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, antiepleptics, 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307632

Sponsors and Collaborators

Janssen-Cilag Farmaceutica Ltda.

Investigators

Study Director:

Janssen-Cilag Farmaceutica Ltda. Clinical Trial

Janssen-Cilag Farmaceutica Ltda.

More Information

No publications provided

Study ID Numbers:	CR002962
Study First Received:	March 24, 2006
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00307632 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Janssen-Cilag Farmaceutica Ltda.:

hormonal patch
Contraception

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Estradiol 17 beta-cypionate

Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate

ClinicalTrials.gov processed this record on February 08, 2010