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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

NCT05617820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2024-04-12

No results posted yet for this study

Summary

Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.

Conditions

  • Dyspareunia

Interventions

DRUG

Estradiol

Vaginal Insert, 4 mcg tablet

DRUG

Imvexxy

Estradiol 4 mcg Vaginal Insert

DRUG

Placebo

Vehicle Vaginal Insert

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • C Dias · Teva Pharmaceuticals USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2024-03-15
Completion
2024-03-15
FDA Drug
Yes

Countries

  • United States
  • El Salvador
  • Honduras

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617820 on ClinicalTrials.gov