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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: Completed Phase 2 study, sponsored by TherapeuticsMD.
NCT02449902 is a Phase 2 study that has completed, run by TherapeuticsMD. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02449902 record still lists
NCT02449902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02449902 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02449902's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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
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