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NCT02449902 · ClinicalTrials.gov registry record · Phase 2
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
A Phase 2 study, sponsored by TherapeuticsMD.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02449902 is a Phase 2 study that has completed, run by TherapeuticsMD. The registered enrollment target is 50 participants.
The verdict
NCT02449902, a Phase 2 study, has completed, sponsored by TherapeuticsMD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints. In addition, the systemic exposure to estradiol from single and multiple doses of TX-12-004-HR was to be investigated.
Interventions
- DRUG placebo
- DRUG Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02449902
The ClinicalTrials.gov registry entry for NCT02449902 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TherapeuticsMD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02449902 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02449902 about?
NCT02449902 is a clinical study titled "TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy". The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints. In addition, the system...
What is the current status of trial NCT02449902?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2013-07. Estimated completion is 2013-09.
What interventions are being tested in trial NCT02449902?
The interventions under investigation include: placebo (DRUG), Estradiol (DRUG).
Who is sponsoring clinical trial NCT02449902?
This trial is sponsored by TherapeuticsMD, which has 5 total clinical trials registered on ClinicalTrials.gov.
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