Who is sponsoring NCT04232813?

NCT04232813 is sponsored by Instituto Palacios.

What drugs are being tested in NCT04232813?

Interventions in NCT04232813: Estradiol 10 MCG Vaginal Tablet [VAGIFEM], Promestriene Vaginal.

What condition does NCT04232813 study?

NCT04232813 studies Vulvovaginal Atrophy.

Is NCT04232813 still recruiting?

NCT04232813 is currently completed. Last updated 11 February 2021.

Last reviewed 2021-02-11 · How we verify

NCT04232813

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

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Completed Phase 3 Last updated 11 February 2021

What this trial tests

Phase 3 trial testing Estradiol 10 MCG Vaginal Tablet [VAGIFEM] in Vulvovaginal Atrophy in 120 participants. Completed in 30 November 2020.

Timeline

9 January 2020

Primary endpoint
30 June 2020

30 November 2020

Quick facts

Lead sponsor	Instituto Palacios
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	9 January 2020
Primary completion	30 June 2020
Estimated completion	30 November 2020
Sites	1 location across Spain

Drugs / interventions tested

Estradiol 10 MCG Vaginal Tablet [VAGIFEM] — full drug profile →
Promestriene Vaginal — full drug profile →

Conditions studied

Vulvovaginal Atrophy — all drugs for Vulvovaginal Atrophy →

Sponsor

Instituto Palacios — full company profile →

Who can join

45 and older, female only, with Vulvovaginal Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).

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 recruiting trials for Vulvovaginal Atrophy

Currently open trials in the same condition.

NCT05562518 — GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therap · Phase 4 · active not recruiting

Other Instituto Palacios trials

Trials by the same sponsor.

NCT03385551 — Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream · completed
NCT04039555 — Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER) · NA · completed
NCT03923985 — Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora · NA · completed
NCT03452696 — Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate · Phase 3 · completed

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 NCT04232813 (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 Instituto Palacios
Last refreshed: 11 February 2021

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/NCT04232813.

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