NCT05617820

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 Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Inserts 4 mcg (Teva Pharmaceuticals, Inc.) With IMVEXXY® (Estradiol Vaginal Inserts) (TherapeuticsMD, Inc.) in the Treatment of Dyspareunia in Women With Vulvar and Vaginal Atrophy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,050 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Dyspareunia

Interventions

Type	Name	Description
DRUG	Estradiol	Vaginal Insert, 4 mcg tablet
DRUG	Imvexxy	Estradiol 4 mcg Vaginal Insert
DRUG	Placebo	Vehicle Vaginal Insert

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2022-11-16
• Last updated: 2024-04-12

Locations

48 sites across 3 countries: United States, El Salvador, Honduras

Regulatory

• FDA-regulated drug study