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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 is a Phase 4 study that has completed, run by Duramed Research. The registered enrollment target is 157 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00592839
The ClinicalTrials.gov registry entry for NCT00592839 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 157 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 is the first listed.
NCT00592839 reports 0 study locations.
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.
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