An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol

PHASE4CompletedINTERVENTIONAL
Enrollment

580

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

December 31, 2004

Study Completion Date

December 31, 2004

Conditions
Contraception
Interventions
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).

Trial Locations (12)

Unknown

Belo Horizonte

Botucatu

Brasília

Curitiba

Goiânia

Porto Alegre

Ribeirão Preto

São Paulo

Sorocaba

Mexico City

México

Monterrey

All Listed Sponsors
lead

Janssen-Cilag Farmaceutica Ltda.

INDUSTRY

NCT00307632 - An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol | Biotech Hunter | Biotech Hunter