Contraceptive UsagePhase 3SimplifyNCT01140217
Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception
A Phase 3 study testing Norethindrone Acetate in people with Contraceptive Usage, run by Watson Pharmaceuticals at 53 sites in United States.
Trial summary
The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated. 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
- Contraceptive Usage
- What is being tested?
- Norethindrone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,659 participants
- Where
- 53 sitesUnited States
- Study dates
- May 2010to Mar 2012
- 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 females
- 18-45 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active and at risk of becoming pregnant
Who cannot join
- History of infertility
- Known contraindications to progestogen administration
- Pap smear suggestive of a high-grade precancerous lesion(s)
- Clinically significant deviation from normal in any of the screening tests or exams
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Watson Investigational Site
Albuquerque, New Mexico
Watson Investigational Site
Ann Arbor, Michigan
Watson Investigational Site
Atlanta, Georgia
Watson Investigational Site
Austin, Texas
Watson Investigational Site
Aventura, Florida
Watson Investigational Site
Birmingham, Alabama
Watson Investigational Site
Chandler, Arizona
Watson Investigational Site
Chapel Hill, North Carolina
Watson Investigational Site
Chicago, Illinois
Watson Investigational Site
Cleveland, Ohio
Watson Investigational Site
Columbia, South Carolina
Watson Investigational Site
Columbus, Ohio
Watson Investigational Site
Dallas, Texas
Watson Investigational Site
Daytona Beach, Florida
Watson Investigational Site
Decatur, Georgia
Watson Investigational Site
Denver, Colorado
Watson Investigational Site
Edina, Minnesota
Watson Investigational Site
Garden Grove, California
Watson Investigational Site
Greer, South Carolina
Watson Investigational Site
Haverhill, Massachusetts
Watson Investigational Site
Hilton Head Island, South Carolina
Watson Investigational Site
Houston, Texas
Watson Investigational Site
Jacksonville, Florida
Watson Investigational Site
Kalamazoo, Michigan
Watson Investigational Site
La Mesa, California
Watson Investigational Site
Lake Worth, Florida
Watson Investigational Site
Las Vegas, Nevada
Watson Investigational Site
Lawrenceville, New Jersey
Watson Investigational Site
Little Rock, Arkansas
Watson Investigational Site
Marrero, Louisiana
Watson Investigational Site
Medford, Oregon
Watson Investigational Site
Miami, Florida
Watson Investigational Site
Mobile, Alabama
Watson Investigational Site
Montgomery, Alabama
Watson Investigational Site
Nashville, Tennessee
Watson Investigational Site
New Bern, North Carolina
Watson Investigational Site
New Orleans, Louisiana
Watson Investigational Site
New York, New York
Watson Investigational Site
Newark, Delaware
Watson Investigational Site
Norfolk, Virginia
Watson Investigational Site
North Miami, Florida
Watson Investigational Site
Overland Park, Kansas
Watson Investigational Site
Philadelphia, Pennsylvania
Watson Investigational Site
Pinellas Park, Florida
Watson Investigational Site
Raleigh, North Carolina
Watson Investigational Site
Salt Lake City, Utah
Watson Investigational Site
San Antonio, Texas
Watson Investigational Site
San Diego, California
Watson Investigational Site
Sandy Springs, Georgia
Watson Investigational Site
Sarasota, Florida
Watson Investigational Site
Savannah, Georgia
Watson Investigational Site
Seattle, Washington
Watson Investigational Site
Washington D.C., District of Columbia
About this study
Official title: An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System
The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
Read the detailed description
An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.
- Conditions
- Contraceptive Usage
- Being tested
- Norethindrone Acetate
- Keywords
- contraception, pregnancy
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethindrone AcetateDrug
Also called NEA TDS
Norethindrone Acetate Transdermal Delivery System
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Norethindrone Acetate Transdermal Delivery System Receives: Drug: Norethindrone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim E Caramelli, MS, Study director, Watson Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140217
- Sponsor's protocol ID
- NE0906
- Acronym
- Simplify
- Status last verified
- Sep 2013
- First submitted
- 18 May 2010
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System
- ClinicalTrials.gov ID
- NCT01140217
- Acronym / sponsor ID
- Simplify / NE0906
- Conditions
- Contraceptive Usage
- Keywords
- contraception, pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,659 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Jun 2010 (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 determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
Detailed description
An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Drug: Norethindrone AcetateNorethindrone Acetate Transdermal Delivery System |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy females
- 18-45 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active and at risk of becoming pregnant
Key exclusion criteria (4 listed)
- History of infertility
- Known contraindications to progestogen administration
- Pap smear suggestive of a high-grade precancerous lesion(s)
- Clinically significant deviation from normal in any of the screening tests or exams
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 |
|---|---|---|
| Norethindrone AcetateAlso: NEA TDSNorethindrone Acetate Transdermal Delivery System | Drug | Active treatment |
Primary outcome
Pregnancy Rate
Time frame: 1 year
The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment.
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 19 Sep 2013.
Related trials for Contraceptive Usage
Enrolling by invitation
A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Contraceptive Usage, Contraceptive Behavior
Not yet recruitingPhase 3
Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System
Contraceptive Usage
RecruitingPhase 4
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Contraceptive Usage
Not yet recruiting
Peer-led Service Delivery Model for Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe
HIV Prevention, Contraceptive Usage
Active, not recruiting
Sexual Health Empowerment for Women's Health
Cervical Cancer, Breast Cancer
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.
Kim E Caramelli, MS study director
Watson Pharmaceuticals, Inc.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Norethindrone Acetate in people with Contraceptive Usage, run by Watson Pharmaceuticals at 53 sites in United States.
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 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. 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 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?
Pregnancy Rate (time frame: 1 year). 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 19 Sep 2013; AzTrials last refreshed its copy on 7 Nov 2026.