NCT05617820 is a Phase 3 clinical trial of Estradiol in Dyspareunia, sponsored by Teva Pharmaceuticals USA.

Who is sponsoring NCT05617820?

NCT05617820 is sponsored by Teva Pharmaceuticals USA.

What drugs are being tested in NCT05617820?

Interventions in NCT05617820: Estradiol, Imvexxy, Placebo.

What condition does NCT05617820 study?

NCT05617820 studies Dyspareunia.

Is NCT05617820 still recruiting?

NCT05617820 is currently completed. Last updated 12 April 2024.

Last reviewed 2024-04-12 · How we verify

NCT05617820

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 12 April 2024

What this trial tests

Phase 3 trial testing Estradiol in Dyspareunia in 1,050 participants. Completed in 15 March 2024.

Timeline

15 November 2022

Primary endpoint
15 March 2024

15 March 2024

Quick facts

Lead sponsor	Teva Pharmaceuticals USA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,050
Start date	15 November 2022
Primary completion	15 March 2024
Estimated completion	15 March 2024
Sites	48 locations across El Salvador, United States, Honduras

Drugs / interventions tested

Estradiol (ESTRADIOL) — full drug profile →
Imvexxy — full drug profile →
Placebo

Conditions studied

Dyspareunia — all drugs for Dyspareunia →

Sponsor

Teva Pharmaceuticals USA — full company profile →

Who can join

Adults 40 to 75, female only, with Dyspareunia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Estradiol

Trials testing the same drug.

NCT05457972 — Postpartum Vaginal Estrogen for Breastfeeding Patients · Phase 4 · recruiting
NCT06253702 — Brain Blood Flow Responses to Stress: Sex Differences · Phase 4 · completed
NCT06005610 — Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy · Phase 2 · terminated
NCT06116201 — Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women · NA · completed
NCT04192266 — Estrogen and Fear in PTSD · Phase 3 · completed

Other recruiting trials for Dyspareunia

Currently open trials in the same condition.

NCT06891690 — Use of TDCS Stimulation in Neurological and Gynaecological Conditions · NA · recruiting
NCT06397885 — Prospective on Market Patient-reported Outcomes for Milli · active not recruiting
NCT05761275 — Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach · NA · recruiting
NCT05631665 — Genital Laser Treatment in Postmenopausal Patients · NA · active not recruiting

Other Teva Pharmaceuticals USA trials

Trials by the same sponsor.

NCT06742957 — Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis · Phase 3 · completed
NCT05550337 — Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris · Phase 3 · completed
NCT04976192 — Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria · Phase 3 · completed
NCT04729621 — A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis · Phase 3 · completed
NCT02246920 — Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Pati · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05617820 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Pharmaceuticals USA
Last refreshed: 12 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05617820.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing