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NCT02253173 · ClinicalTrials.gov registry record · Phase 3

Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

A Phase 3 study, sponsored by TherapeuticsMD.

Completed
Registry status
Phase 3
Development phase
764
Enrollment target

NCT02253173: Completed Phase 3 study, sponsored by TherapeuticsMD.

NCT02253173 is a Phase 3 study that has completed, run by TherapeuticsMD. The registered enrollment target is 764 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02253173, a Phase 3 study, has completed, sponsored by TherapeuticsMD.

COMPLETED
Registry status
Phase 3
Development phase
764 participants
Enrollment target

Study Summary

This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.

Primary Outcome

• Change from Baseline to Week 12 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo

Interventions

  • DRUG Placebo
  • DRUG Estradiol

Trial Details

FieldValue
Enrollment Target 764 participants
Start Date 2014-09
Est. Completion 2015-10
Phase Phase 3
TherapeuticsMD

5 total trials

What the finished NCT02253173 record still lists

NCT02253173 is an interventional study that assigns participants to a tested intervention. The registered 764 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02253173 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02253173 about?

NCT02253173 is a clinical study titled "Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women". This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.

What is the current status of trial NCT02253173?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 764 participants. The study started on 2014-09. Estimated completion is 2015-10.

What interventions are being tested in trial NCT02253173?

The interventions under investigation include: Placebo (DRUG), Estradiol (DRUG).

Who is sponsoring clinical trial NCT02253173?

This trial is sponsored by TherapeuticsMD, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02253173's enrollment target sits among peer trials

764 449th of 2000 higher than 1,552 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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Source: ClinicalTrials.gov NCT02253173, the US trial registry maintained by the National Library of Medicine. NCT02253173 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.