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NCT00592839 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
A Phase 4 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 157
- Enrollment target
NCT00592839: Completed Phase 4 study, sponsored by Duramed Research.
NCT00592839 is a Phase 4 study that has completed, run by Duramed Research. The registered enrollment target is 157 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00592839, a Phase 4 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 157 participants
- Enrollment target
Study Summary
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.
Primary Outcome
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Interventions
- DRUG Placebo
- DRUG SCE-B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
What the finished NCT00592839 record still lists
NCT00592839 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00592839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00592839 about?
NCT00592839 is a clinical study titled "Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women". This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matc...
What is the current status of trial NCT00592839?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 157 participants. The study started on 2007-12. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00592839?
The interventions under investigation include: Placebo (DRUG), SCE-B (DRUG).
Who is sponsoring clinical trial NCT00592839?
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 NCT00592839's enrollment target sits among peer trials
157 519th of 2000 higher than 1,480 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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