ContraceptionPhase 3NCT00477633
Study of Safety and Efficacy of an Oral Contraceptive
A Phase 3 study testing Norethindrone/ethinyl estradiol in people with Contraception, run by Warner Chilcott at 63 sites in United States.
Trial summary
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product. 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
- What is being tested?
- Norethindrone/ethinyl estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 63 sitesUnited States
- Study dates
- Jun 2007to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18-45
- At risk for pregnancy
- History of regular cycles
Who cannot join
- Contraindications for use of hormonal contraception
- Conditions which affect the absorption or metabolism of steroid hormones
- BMI>35
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Warner Chilcott Investigational Site
Amite, Louisiana, 70422
Warner Chilcott Investigational Site
Arkansas City, Kansas, 67005
Warner Chilcott Investigational Site
Austin, Texas, 78748
Warner Chilcott Investigational Site
Austin, Texas, 78759
Warner Chilcott Investigational Site
Berlin, New Jersey, 08009
Warner Chilcott Investigational Site
Boynton Beach, Florida, 33472
Warner Chilcott Investigational Site
Brooksville, Florida, 34613
Warner Chilcott Investigational Site
Cary, North Carolina, 27511
Warner Chilcott Investigational Site
Castle Rock, Colorado, 80108
Warner Chilcott Investigational Site
Champaign, Illinois, 61820
Warner Chilcott Investigational Site
Chandler, Arizona, 85224
Warner Chilcott Investigational Site
Chaska, Minnesota, 55318
Warner Chilcott Investigational Site
Clearwater, Florida, 33759
Warner Chilcott Investigational Site
Cleveland, Ohio, 44122
Warner Chilcott Investigational Site
Columbia, South Carolina, 29201
Warner Chilcott Investigational Site
Dallas, Texas, 75234
Warner Chilcott Investigational Site
Decatur, Georgia, 30034
Warner Chilcott Investigational Site
Denver, Colorado, 80218
Warner Chilcott Investigational Site
Edison, New Jersey, 08817
Warner Chilcott Investigational Site
Gainesville, Florida, 32607
Warner Chilcott Investigational Site
Houston, Texas, 77030
Warner Chilcott Investigational Site
Indianapolis, Indiana, 46250
Warner Chilcott Investigational Site
Jacksonville, Florida, 32207
Warner Chilcott Investigational Site
Lakewood, Colorado, 80228
Warner Chilcott Investigational Site
Lawrenceville, New Jersey, 08648
Warner Chilcott Investigational Site
Leesburg, Florida, 34748
Warner Chilcott Investigational Site
Lexington, Kentucky, 40509
Warner Chilcott Investigational Site
Louisville, Kentucky, 40291
Warner Chilcott Investigational Site
Magna, Utah, 84044
Warner Chilcott Investigational Site
Marrero, Louisiana, 70072
Warner Chilcott Investigational Site
Medford, Oregon, 97504
Warner Chilcott Investigational Site
Miami, Florida, 33143
Warner Chilcott Investigational Site
Miami, Florida, 33186
Warner Chilcott Investigational Site
Moorestown, New Jersey, 08051
Warner Chilcott Investigational Site
New Bern, North Carolina, 28562
Warner Chilcott Investigational Site
New York, New York, 10016
Warner Chilcott Investigational Site
Norfolk, Virginia, 23507
Warner Chilcott Investigational Site
Oklahoma City, Oklahoma, 73112
Warner Chilcott Investigational Site
Pembroke Pines, Florida, 33021
Warner Chilcott Investigational Site
Peoria, Illinois, 61615
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, 19114
Warner Chilcott Investigational Site
Phoenix, Arizona, 85032
Warner Chilcott Investigational Site
Phoenix, Arizona, 85037
Warner Chilcott Investigational Site
Phoenix, Arizona, 85050
Warner Chilcott Investigational Site
Pittsburgh, Pennsylvania, 15206
Warner Chilcott Investigational Site
Pottstown, Pennsylvania, 19464-3224
Warner Chilcott Investigational Site
Raleigh, North Carolina, 27612
Warner Chilcott Investigational Site
Richmond, Virginia, 23233
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84109
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84121
Warner Chilcott Investigational Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Site
San Diego, California, 92103
Warner Chilcott Investigational Site
San Diego, California, 92108
Warner Chilcott Investigational Site
St. Petersburg, Florida, 33709
Warner Chilcott Investigational Site
Tempe, Arizona, 85282
Warner Chilcott Investigational Site
Tucson, Arizona, 85712
Warner Chilcott Investigational Site
Virginia Beach, Virginia, 23456
Warner Chilcott Investigational Site
Vista, California, 92083
Warner Chilcott Investigational Site
West Palm Beach, Florida, 33401
Warner Chilcott Investigational Site
West Palm Beach, Florida, 33409
Warner Chilcott Investigational Site
West Valley City, Utah, 84120
Warner Chilcott Investigational Site
Wichita, Kansas, 67207
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
- Conditions
- Contraception
- Being tested
- Norethindrone/ethinyl estradiol
- Keywords
- Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethindrone/ethinyl estradiolDrug
1 tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Norethindrone/ethinyl estradiol | Experimental | 1 tablet per day Receives: Drug: Norethindrone/ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pearl Index, 18-35 Years, MITT Population
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
Measured: 13 cycles (28 days each), approximately 364 days
Secondary outcomes (2)
Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Measured: 12 cycles (28 days each), approximately 336 days
Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain "mean median duration" of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean \& SD of those quantities calculated.
Measured: 12 cycles (28 days each), approximately 336 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herman Ellman, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477633
- Sponsor's protocol ID
- PR-00207
- Status last verified
- Apr 2013
- First submitted
- 22 May 2007
- Last updated
- 22 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
- ClinicalTrials.gov ID
- NCT00477633
- Acronym / sponsor ID
- PR-00207
- Conditions
- Contraception
- Keywords
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Posted 24 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norethindrone/ethinyl estradiol | Experimental | Drug: Norethindrone/ethinyl estradiol1 tablet per day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Women
- Age 18-45
- At risk for pregnancy
- History of regular cycles
Key exclusion criteria (3 listed)
- Contraindications for use of hormonal contraception
- Conditions which affect the absorption or metabolism of steroid hormones
- BMI>35
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/ethinyl estradiol1 tablet per day | Drug | Norethindrone/ethinyl estradiol |
Primary outcome
Pearl Index, 18-35 Years, MITT Population
Time frame: 13 cycles (28 days each), approximately 364 days
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
2 secondary outcomes
Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Time frame: 12 cycles (28 days each), approximately 336 days
Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Time frame: 12 cycles (28 days each), approximately 336 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herman Ellman study director
Sponsor GmbH
63 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/ethinyl estradiol in people with Contraception, run by Warner Chilcott at 63 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 3 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 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?
Yes. Results are posted in the registry (first posted 24 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pearl Index, 18-35 Years, MITT Population (time frame: 13 cycles (28 days each), approximately 364 days). 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 22 Apr 2013.