Who is sponsoring NCT03281655?

NCT03281655 is sponsored by University of Messina.

What drugs are being tested in NCT03281655?

Interventions in NCT03281655: Visnadine, prenylflavonoids and bovine colostrum.

What condition does NCT03281655 study?

NCT03281655 studies Vulvovaginal Atrophy, Menopause.

Is NCT03281655 still recruiting?

NCT03281655 is currently completed. Last updated 23 March 2020.

Last reviewed 2020-03-23 · How we verify

NCT03281655

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

Effects of a New Vaginal Cream Containing Visnadine, Prenylflavonoids and Bovine Colostrum in Postmenopausal Sexually Active Women Affected by Vulvovaginal Atrophy: a Prospective Cohort Analysis

Completed Phase 2 Last updated 23 March 2020

What this trial tests

Phase 2 trial testing Visnadine, prenylflavonoids and bovine colostrum in Vulvovaginal Atrophy in 54 participants. Completed in 1 January 2018.

Timeline

1 December 2016

Primary endpoint
1 May 2017

1 January 2018

Quick facts

Lead sponsor	University of Messina
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 December 2016
Primary completion	1 May 2017
Estimated completion	1 January 2018

Drugs / interventions tested

Visnadine, prenylflavonoids and bovine colostrum — full drug profile →

Conditions studied

Vulvovaginal Atrophy — all drugs for Vulvovaginal Atrophy →
Menopause — all drugs for Menopause →

Sponsor

University of Messina

Who can join

Adults 45 to 70, female only, with Vulvovaginal Atrophy or Menopause. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Vaginal health index score (VHIS) evaluation
Time frame: Post-treatment (15 days)
Elasticity, fluid volume and consistency, pH, epithelial integrity and moisture.
Female sexual function index (FSFI) questionnaire
Time frame: Post-treatment (15 days)
Desire, arousal, lubrication, orgasm, satisfaction and pain.

Sponsor's own description

The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA). In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All women will undergo vaginal health index score (VHIS) evaluation and will complete the female sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days of vaginal cream treatment with one application per day (T1). All the side effects will be recorded and an independent data safety and monitoring committee will evaluate the results of the study.

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 University of Messina trials

Trials by the same sponsor.

NCT07106463 — Microbiota: Its Role in Chronic Inflammation, IDB and Risk of Colorectal Cancer. Evaluation of a Predictive Prognostic M · active not recruiting
NCT05496322 — Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure · NA · completed
NCT05122741 — Modulation of Fibrosis-inducing Pathways in Acute Myocardial Infarction · unknown
NCT04994379 — Investigating the Effects of Intensity of Transcranial Direct Current Stimulation on Subjective Appetite · NA · terminated
NCT06787781 — Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects · NA · 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 NCT03281655 (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 University of Messina
Last refreshed: 23 March 2020

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/NCT03281655.

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