Status:
COMPLETED
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Contraception
Female Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Triphasil.
Detailed Description
This is an open-label, multicenter, worldwide study to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal patch compared with Triphasil...
Eligibility Criteria
Inclusion
- Healthy, nonpregnant women with regular menstrual cycles
- sexually active and at risk of pregnancy
- 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
- 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
- undiagnosed abnormal vaginal bleeding
- thyroid disorder
- dermal hypersensitivity
- carcinoma of breast, genital tract or other estrogen-dependent neoplasia
- received any depot hormone injection within prior 6 months
- smoking women over 35 years of age.
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1999
Estimated Enrollment :
1494 Patients enrolled
Trial Details
Trial ID
NCT00236795
Start Date
January 1 1997
End Date
March 1 1999
Last Update
June 8 2011
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