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NCT05617820 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy
A Phase 3 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,050
- Enrollment target
NCT05617820: Completed Phase 3 study, sponsored by Teva Pharmaceuticals USA.
NCT05617820 is a Phase 3 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 1,050 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05617820, a Phase 3 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,050 participants
- Enrollment target
Study Summary
Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.
Primary Outcome
% Responders where a "Responder" is defined as a patient with: At least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology; and Vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5
Interventions
- DRUG Placebo
- DRUG Estradiol
- DRUG Imvexxy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,050 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2024-03-15 |
| Phase | Phase 3 |
What the finished NCT05617820 record still lists
NCT05617820 is an interventional study that assigns participants to a tested intervention. Its 1,050 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05617820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05617820 about?
NCT05617820 is a clinical study titled "Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy". Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.
What is the current status of trial NCT05617820?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,050 participants. The study started on 2022-11-15. Estimated completion is 2024-03-15.
What interventions are being tested in trial NCT05617820?
The interventions under investigation include: Placebo (DRUG), Estradiol (DRUG), Imvexxy (DRUG).
Who is sponsoring clinical trial NCT05617820?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05617820's enrollment target sits among peer trials
1,050 282nd of 2000 higher than 1,718 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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