Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Duramed Research.
NCT00196313 is a Phase 2 study that has completed, run by Duramed Research. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")
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 |
What the finished NCT00196313 record still lists
NCT00196313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo tablet is the first listed.
NCT00196313 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00196313's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03339128 · 95 participants · Phase 2
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
- NCT03509961 · 95 participants · Phase 2
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
- NCT03694756 · 95 participants · NA
TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
- NCT04206215 · 95 participants · NA
Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia