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

Contraception Clinical Trial

Official title:

An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17deacetyl-norgestimate and Ethinyl Estradiol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236769
• Other study ID #: CR005500
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: November 15, 2010
• Start date: November 1997
• Est. completion date: October 1999

Study information

• Verified date: November 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1751
• Est. completion date: October 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception
• Female Contraception

Intervention

Drug:
• norelgestromin + ethinyl estradiol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
Secondary	Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information.