ContraceptionPhase 4NCT00307632
An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
A Phase 4 study testing Norelgestromine (NLGM)/ethinyl estradiol (EE) in people with Contraception, run by Janssen-Cilag Farmaceutica Ltda. at 12 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE). Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Norelgestromine (NLGM)/ethinyl estradiol (EE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Feb 2003to Dec 2004
- Phase
- Phase 4
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult females who meet the following selection criteria: Have regular menses occuring every 25-35 days
- Acceptable body mass (< 30) and the weight is < 90 kg
- Has completed her last term pregnancy at least 4 months prior to study admission, is not lactating and has at least one normal menstrual period since her last pregnancy and not breast feeding
- Has a sitting blood pressure systolic < 140 mm/Hg and diastolic < 90 mm/Hg.
Who cannot join
- Has not received a DepoProvera injection or any other depot hormone injection within six months prior to the screening visit
- Has not used / or in current use of barbiturates, antiepileptics, rifampin, griseofulvin, Hypericum perforatum, or other hepatic enzyme-inducing drugs within 30 days prior to the pre-study visit
- Has not a uncontrolled disorder
- No women over the age 35 who smoke.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Brazil9 sites
Study site
Belo Horizonte
Study site
Botucatu
Study site
Brasília
Study site
Curitiba
Study site
Goiânia
Study site
Porto Alegre
Study site
Ribeirão Preto
Study site
São Paulo
Study site
Sorocaba
About this study
The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE).
Read the detailed description
A multicenter, open label, descriptive study. Five hundred requiring contraception will receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive efficacy will be assessed by the Pearl Index and by life table analysis. To assess satisfaction with the weekly transdermal contraceptive patch, this method will be compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2 contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of NLGM and 20 mcg of EE per day.
- Conditions
- Contraception
- Being tested
- Norelgestromine (NLGM)/ethinyl estradiol (EE)
- Keywords
- Contraception, Hormonal patch, Norelgestromine, Ethinyl estradiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norelgestromine (NLGM)/ethinyl estradiol (EE)Drug
Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).
| Study group | Role | What they receive |
|---|---|---|
| Norelgestromine (NLGM)/Ethinyl Estradiol (EE) | Experimental | Not described Receives: Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate Determined by Pearl Index
Pearl Index is the number of pregnancies with use of therapy divided by the number of cycles with therapy use. It is an estimation of the number of pregnancies per 100 woman-years of product use.
Measured: Cycle 6 (Day 168)
Pregnancy Rate Determined by Table of Life Analysis
Pregnancy rate was determined by table of life analysis.
Measured: Cycle 6 (Day 168)
Secondary outcomes (3)
Percentage of Participants With Breakthrough Bleeding and/or Spotting
Percentage of participants with breakthrough bleeding and/or spotting was reported.
Measured: Day 28 of Cycle 1, 3 and 6
Compliance Score
Score of compliance was calculated for each participant by dividing the number of cycles with at least one day without the study drug by the total number of therapy cycles. Average score was calculated for cycle 1 to 6.
Measured: Day 28 of Cycle 1, 2, 3, 4, 5 and 6
Percentage of Participants With Response to Satisfaction Questionnaire
Percentage of participants with response to satisfaction questionnaire was reported for following categories: previous contraceptive, method election, physical well-being, emotional well-being, intermenstrual bleeding and intensity, menstrual flow volume, pre-menstrual symptoms, and easiness in ethinyl estradiol and norelgestromin transdermal patch use.
Measured: Day 28 of Cycle 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startFeb 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Farmaceutica Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Farmaceutica Ltda. Clinical Trial, Study director, Janssen-Cilag Farmaceutica Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307632
- Sponsor's protocol ID
- CR002962
- Other IDs
- NRGEEPCON4015
- Status last verified
- May 2014
- First submitted
- 24 Mar 2006
- Last updated
- 15 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
- ClinicalTrials.gov ID
- NCT00307632
- Acronym / sponsor ID
- CR002962
- Conditions
- Contraception
- Keywords
- Contraception, Hormonal patch, Norelgestromine, Ethinyl estradiol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Janssen-Cilag Farmaceutica Ltda.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 28 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE).
Detailed description
A multicenter, open label, descriptive study. Five hundred requiring contraception will receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive efficacy will be assessed by the Pearl Index and by life table analysis. To assess satisfaction with the weekly transdermal contraceptive patch, this method will be compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2 contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of NLGM and 20 mcg of EE per day.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norelgestromine (NLGM)/Ethinyl Estradiol (EE) | Experimental | Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult females who meet the following selection criteria: Have regular menses occuring every 25-35 days
- Acceptable body mass (< 30) and the weight is < 90 kg
- Has completed her last term pregnancy at least 4 months prior to study admission, is not lactating and has at least one normal menstrual period since her last pregnancy and not breast feeding
- Has a sitting blood pressure systolic < 140 mm/Hg and diastolic < 90 mm/Hg.
Key exclusion criteria (4 listed)
- Has not received a DepoProvera injection or any other depot hormone injection within six months prior to the screening visit
- Has not used / or in current use of barbiturates, antiepileptics, rifampin, griseofulvin, Hypericum perforatum, or other hepatic enzyme-inducing drugs within 30 days prior to the pre-study visit
- Has not a uncontrolled disorder
- No women over the age 35 who smoke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norelgestromine (NLGM)/ethinyl estradiol (EE)Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each). | Drug | Norelgestromine (NLGM)/Ethinyl Estradiol (EE) |
Primary outcome
Pregnancy Rate Determined by Pearl Index
Time frame: Cycle 6 (Day 168)
Pearl Index is the number of pregnancies with use of therapy divided by the number of cycles with therapy use. It is an estimation of the number of pregnancies per 100 woman-years of product use.
Pregnancy Rate Determined by Table of Life Analysis
Time frame: Cycle 6 (Day 168)
Pregnancy rate was determined by table of life analysis.
3 secondary outcomes
Percentage of Participants With Breakthrough Bleeding and/or Spotting
Time frame: Day 28 of Cycle 1, 3 and 6
Compliance Score
Time frame: Day 28 of Cycle 1, 2, 3, 4, 5 and 6
Percentage of Participants With Response to Satisfaction Questionnaire
Time frame: Day 28 of Cycle 1, 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Farmaceutica Ltda. Clinical Trial study director
Janssen-Cilag Farmaceutica Ltda.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norelgestromine (NLGM)/ethinyl estradiol (EE) in people with Contraception, run by Janssen-Cilag Farmaceutica Ltda. at 12 sites in 2 countries.
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 4 inclusion and 4 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 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Brazil, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pregnancy Rate Determined by Pearl Index (time frame: Cycle 6 (Day 168)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2014.