A Study of Efficacy and Safety With the Transdermal Contraceptive System.
November 15, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17deacetyl-norgestimate and Ethinyl Estradiol.
The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control, and compliance with the transdermal contraceptive system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1751
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
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Secondary Outcome Measures
Outcome Measure |
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Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1997
Study Completion (Actual)
October 1, 1999
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
November 17, 2010
Last Update Submitted That Met QC Criteria
November 15, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Estradiol
- Ethinyl Estradiol
- Norelgestromin
Other Study ID Numbers
- CR005500
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.