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A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
NCT00196352 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
Study Locations (11)
North Carolina
- Duramed Investigational Site — Charlotte
- Duramed Investigational Site — Winston-Salem
Virginia
- Duramed Investigational Site — Arlington
- Duramed Investigational Site — Norfolk
Arizona
- Duramed Investigational Site — Tucson
District of Columbia
- Duramed Investigational Site — Washington D.C.
Nebraska
- Duramed Investigational Site — Lincoln
New York
- Duramed Investigational Site — Rochester
Ohio
- Duramed Investigational Site — Columbus
Oklahoma
- Duramed Investigational Site — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2003-05 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00196352
The ClinicalTrials.gov registry entry for NCT00196352 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention — of which Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00196352 reports 11 study locations spanning 9 distinct geographic areas — top geographies include North Carolina, Virginia, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00196352 about?
NCT00196352 is a clinical study titled "A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.". 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.
What is the current status of trial NCT00196352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2003-05. Estimated completion is 2006-11.
What conditions does trial NCT00196352 study?
This clinical trial studies the following conditions: Contraception. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00196352?
The interventions under investigation include: Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00196352?
This trial is sponsored by Duramed Research, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00196352 being conducted?
This trial has 11 study locations across Arizona, District of Columbia, Nebraska, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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