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NCT00196313 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
A Phase 2 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT00196313 is a Phase 2 study that has completed, run by Duramed Research. The registered enrollment target is 95 participants.
The verdict
NCT00196313, a Phase 2 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.
Interventions
- DRUG Placebo tablet
- DRUG levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00196313
The ClinicalTrials.gov registry entry for NCT00196313 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo tablet is the first listed.
NCT00196313 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00196313 about?
NCT00196313 is a clinical study titled "A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain". This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an ad...
What is the current status of trial NCT00196313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2005-05. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00196313?
The interventions under investigation include: Placebo tablet (DRUG), levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets (DRUG).
Who is sponsoring clinical trial NCT00196313?
This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.
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