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NCT00777556 · ClinicalTrials.gov registry record · Phase 3
Emergency Contraception Actual Use Study
A Phase 3 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 343
- Enrollment target
NCT00777556: Completed Phase 3 study, sponsored by Duramed Research.
NCT00777556 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 343 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00777556, a Phase 3 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 343 participants
- Enrollment target
Study Summary
This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.
Primary Outcome
The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.
Interventions
- DRUG DR-104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT00777556 record still lists
NCT00777556 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 1 intervention - of which DR-104 is the first listed.
NCT00777556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00777556 about?
NCT00777556 is a clinical study titled "Emergency Contraception Actual Use Study". This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.
What is the current status of trial NCT00777556?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2008-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00777556?
The interventions under investigation include: DR-104 (DRUG).
Who is sponsoring clinical trial NCT00777556?
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 NCT00777556's enrollment target sits among peer trials
343 1051st of 2000 higher than 948 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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