ContraceptionPhase 2NCT00338052
Study of Bleeding With Extended Administration of an Oral Contraceptive
A Phase 2 study testing Norethindrone 1 mg / ethinyl estradiol 20 mcg in people with Contraception, run by Warner Chilcott at 23 sites in United States.
Trial summary
This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Norethindrone 1 mg / ethinyl estradiol 20 mcg
- How many people
- 207 participants
- Where
- 23 sitesUnited States
- Study dates
- Jun 2006to May 2007
- Phase
- Phase 2
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women
- Age 25-40
- History of regular cycles
Who cannot join
- Current or recent (within 2 months) users of hormonal contraceptives
- Contraindications for use of hormonal contraception
- Conditions which affect the absorption or metabolism of steroid hormones
- BMI > 35
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Warner Chilcott Investigational Site
Boynton Beach, Florida, 33437
Warner Chilcott Investigational Site
Carmichael, California, 95608
Warner Chilcott Investigational Site
Decatur, Georgia, 30034
Warner Chilcott Investigational Site
Greenville, South Carolina, 29607
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
Miami, Florida, 33143
Warner Chilcott Investigational Site
Miami, Florida, 33186
Warner Chilcott Investigational Site
New Bern, North Carolina, 28562
Warner Chilcott Investigational Site
Peoria, Illinois, 61615
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, 19114
Warner Chilcott Investigational Site
Phoenix, Arizona, 85031
Warner Chilcott Investigational Site
Phoenix, Arizona, 85050
Warner Chilcott Investigational Site
Pleasant Grove, Utah, 84062
Warner Chilcott Investigational Site
Roswell, Georgia, 30075
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84017
Warner Chilcott Investigational Site
Sandy City, Utah, 84070
Warner Chilcott Investigational Site
Seattle, Washington, 98105
Warner Chilcott Investigational Site
Tempe, Arizona, 85283
Warner Chilcott Investigational Site
Virginia Beach, Virginia, 23456
Warner Chilcott Investigational Site
West Palm Beach, Florida, 33401
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets
This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.
- Conditions
- Contraception
- Being tested
- Norethindrone 1 mg / ethinyl estradiol 20 mcg
- Keywords
- Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethindrone 1 mg / ethinyl estradiol 20 mcgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding/spotting days/episodes per treatment cycle
Secondary outcomes (1)
Satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2007
- Study completionMay 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Herman Ellman, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338052
- Sponsor's protocol ID
- PR-02306
- Status last verified
- May 2008
- First submitted
- 16 Jun 2006
- Last updated
- 8 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets
- ClinicalTrials.gov ID
- NCT00338052
- Acronym / sponsor ID
- PR-02306
- Conditions
- Contraception
- Keywords
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 20 Jun 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.
This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women
- Age 25-40
- History of regular cycles
Key exclusion criteria (4 listed)
- Current or recent (within 2 months) users of hormonal contraceptives
- 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 1 mg / ethinyl estradiol 20 mcg | Drug | – |
Primary outcome
Number of bleeding/spotting days/episodes per treatment cycle
1 secondary outcome
Satisfaction
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 8 May 2008.
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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, MD study director
Sponsor GmbH
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norethindrone 1 mg / ethinyl estradiol 20 mcg in people with Contraception, run by Warner Chilcott at 23 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 3 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 8 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of bleeding/spotting days/episodes per treatment cycle. 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 8 May 2008.