A Study of Efficacy and Safety With the Transdermal Contraceptive System.

NCT ID: NCT00236769

Last Updated: 2010-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1751 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-11-30
• Study Completion Date: 1999-10-31

Brief Summary

The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control, and compliance with the transdermal contraceptive system.

Detailed Description

This is an open-label, multicenter, global study to evaluate the contraceptive efficacy, cycle control, safety, compliance and subject satisfaction of the transdermal contraceptive system. Sixteen hundred healthy women will wear the contraceptive patch for either 6 or 13 cycles. The first 530 subjects will wear the patch for 13 cycles, and all subsequent subjects will wear the patch for 6 cycles. At admission Visit 1, study drug (plus 3 reserve patches) and diary cards are dispensed for Cycle 1; first patch application will be on the first day of menses. Study drug and diary cards are dispensed on day 28 of Cycle 1 (Visit 2) for Cycles 2 and 3, on day 28 of Cycle 3 (Visit 3) for Cycles 4 to 6, on day 28 of Cycle 6 (Visit 4) for Cycles 7 to 9, and on day 28 of Cycle 9 (Visit 5) for Cycles10 to13. At each of these visits, diary cards and empty medication packages are collected. Final study visits are on day 28 of Cycles 6 and 13. Diary card information is used to record compliance and bleeding information (to assess cycle control). Contraceptive efficacy is assessed by means of the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety evaluations are based on adverse events, which are collected throughout the study, and changes in gynecologic examinations, vital signs, and laboratory results from admission to final visit. Each transdermal contraceptive patch, containing 6 mg NGM and 0.75 mg EE, and delivering 250 ug 17-dNGM and 25 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks. The fourth week is patch-free. The patch can be worn on: upper arm or torso, buttock, or abdomen.

Conditions

Contraception; Female Contraception

Keywords

contraception; transdermal contraception; hormonal, steroidal contraception; ethinyl estradiol; progesterone

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

norelgestromin + ethinyl estradiol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy women with regular menstrual cycles
• sexually active and at risk of pregnancy
• nonpregnant
• acceptable body mass index (BMI)
• last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since
• sitting BP<140mmHg/<90mmHg
• 1 normal menstrual cycle since removal of IUD or norplant
• agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment
• agree not to use other systemic steroid medication

Exclusion Criteria

• Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders
• cerebral vascular or coronary artery disease, hypertension, or severe migraines
• liver tumor resulting from estrogen-containing products
• diabetes mellitus
• cholestatic jaundice, liver or renal disease
• abnormal PAP smear
• thyroid disorder
• dermal hypersensitivity
• carcinoma of breast, endometrium or other estrogen-dependent neoplasia
• substance abuse
• received experimental drug within prior 30 days
• smoking women over 35 years of age.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

Smallwood GH, Meador ML, Lenihan JP, Shangold GA, Fisher AC, Creasy GW; ORTHO EVRA/EVRA 002 Study Group. Efficacy and safety of a transdermal contraceptive system. Obstet Gynecol. 2001 Nov;98(5 Pt 1):799-805. doi: 10.1016/s0029-7844(01)01534-4.

Reference Type: RESULT

PMID: 11704172 (View on PubMed)

Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002 Feb;77(2 Suppl 2):S13-8. doi: 10.1016/s0015-0282(01)03275-7.

Reference Type: RESULT

PMID: 11849631 (View on PubMed)

Zacur HA, Hedon B, Mansour D, Shangold GA, Fisher AC, Creasy GW. Integrated summary of Ortho Evra/Evra contraceptive patch adhesion in varied climates and conditions. Fertil Steril. 2002 Feb;77(2 Suppl 2):S32-5. doi: 10.1016/s0015-0282(01)03262-9.

Reference Type: RESULT

PMID: 11849634 (View on PubMed)

Other Identifiers

CR005500

Identifier Type: -

Identifier Source: org_study_id