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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00236769

Collaborator

(none)

1,751

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contraception Female Contraception	Drug: norelgestromin + ethinyl estradiol	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1751 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 1997

Actual Study Completion Date :

Oct 1, 1999

Outcome Measures

Primary Outcome Measures

Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study. []

Secondary Outcome Measures

Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.