ContraceptionPhase 3NCT00196352
A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
A Phase 3 study testing Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets in people with Contraception, run by Duramed Research at 11 sites in United States.
Trial summary
This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2003to Nov 2006
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant in the earlier Phase 3 Seasonique clinical trial
Who cannot join
- Any contraindication to the use of oral contraceptives
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Duramed Investigational Site
Arlington, Virginia, 22203
Duramed Investigational Site
Charlotte, North Carolina, 28209
Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Lincoln, Nebraska, 68510
Duramed Investigational Site
Nashville, Tennessee, 37203
Duramed Investigational Site
Norfolk, Virginia, 23507
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112
Duramed Investigational Site
Rochester, New York, 14609
Duramed Investigational Site
Tucson, Arizona, 85715
Duramed Investigational Site
Washington D.C., District of Columbia, 20006
Duramed Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Prospective, Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive, Seasonique, Which Utilizes Ethinyl Estradiol During the Pill-free Interval.
This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.
Read the detailed description
This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.
- Conditions
- Contraception
- Being tested
- Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
- Keywords
- oral contraceptives, birth control, ethinyl estradiol, pregnancy prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tabletsDrug
Also called Seasonique
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Investigator reports of adverse events
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionNov 2006
- Study completionNov 2006
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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Duramed Protocol Chair, Study chair, Duramed Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196352
- Sponsor's protocol ID
- PSE-304
- Status last verified
- Apr 2014
- First submitted
- 12 Sep 2005
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multiple Site Study to Evaluate the Safety of an Extended Cycle Combination Oral Contraceptive, Seasonique, Which Utilizes Ethinyl Estradiol During the Pill-free Interval.
- ClinicalTrials.gov ID
- NCT00196352
- Acronym / sponsor ID
- PSE-304
- Conditions
- Contraception
- Keywords
- oral contraceptives, birth control, ethinyl estradiol, pregnancy prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 20 Sep 2005 (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 study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.
Detailed description
This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participant in the earlier Phase 3 Seasonique clinical trial
Key exclusion criteria (1 listed)
- Any contraindication to the use of oral contraceptives
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 |
|---|---|---|
| Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tabletsAlso: Seasonique1 tablet daily | Drug | 1 |
Primary outcome
Patient and Investigator reports of adverse events
Time frame: Duration of Study
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 Apr 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.
Duramed Protocol Chair study chair
Duramed Research, Inc.
11 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 Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets in people with Contraception, run by Duramed Research at 11 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 1 inclusion and 1 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Patient and Investigator reports of adverse events (time frame: Duration of Study). 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 Apr 2014.