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ContraceptionPhase 3NCT00236769

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

A Phase 3 study testing norelgestromin + ethinyl estradiol in people with Contraception and Female Contraception, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception, Female Contraception
What is being tested?
norelgestromin + ethinyl estradiol
How many people
1,751 participants
Where
No sites listed yet
Study dates
Nov 1997to Oct 1999
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

About this study

Official title: 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.

Read the 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.

Being tested
norelgestromin + ethinyl estradiol
Keywords
contraception, transdermal contraception, hormonal, steroidal contraception, ethinyl estradiol, progesterone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • norelgestromin + ethinyl estradiolDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2005 (estimated)
  2. Study startNov 1997
  3. Study completionOct 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,751 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00236769
Sponsor's protocol ID
CR005500
Status last verified
Nov 2010
First submitted
7 Oct 2005
Last updated
17 Nov 2010
Results posted
No

Publications

  • 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.

    PubMed 11704172

  • 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.

    PubMed 11849631

  • 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.

    PubMed 11849634

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing norelgestromin + ethinyl estradiol in people with Contraception and Female Contraception, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00236769, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2010.

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