Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.

NCT00261482 | Completed Phase 4

• 1 other identifier: CR002905
• Study Type: interventional
• Target: 778
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Contraception; Female Contraception

Keywords

contraception; female contraception; hormonal contraception; transdermal contraception; EVRA; estrogen; progestin; ethinyl estradiol; norelgestromin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.

Interventions

norelgestromin + ethinyl estradiol DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Regular menstrual cycles
• sexually active and at risk of pregnancy
• nonpregnant
• normal Pap smear

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

MeSH Terms

Interventions

norelgestromin; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 5, 2005
• Study Start: July 1, 2003
• Study Completion: December 1, 2004
• Last Updated: November 16, 2010

Record last verified: 2010-11