Who is sponsoring NCT04545255?

NCT04545255 is sponsored by Rambam Health Care Campus.

What drugs are being tested in NCT04545255?

Interventions in NCT04545255: Shockwave treatment.

What condition does NCT04545255 study?

NCT04545255 studies Provoked Vestibulodynia.

Is NCT04545255 still recruiting?

NCT04545255 is currently completed. Last updated 10 September 2020.

Last reviewed 2020-09-10 · How we verify

NCT04545255

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

The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)

Completed NA Last updated 10 September 2020

What this trial tests

NA trial testing Shockwave treatment in Provoked Vestibulodynia in 32 participants. Completed in 20 January 2020.

Timeline

21 June 2018

Primary endpoint
30 October 2019

20 January 2020

Quick facts

Lead sponsor	Rambam Health Care Campus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	32
Start date	21 June 2018
Primary completion	30 October 2019
Estimated completion	20 January 2020
Sites	1 location across Israel

Drugs / interventions tested

Shockwave treatment

Conditions studied

Provoked Vestibulodynia — all drugs for Provoked Vestibulodynia →

Sponsor

Rambam Health Care Campus — full company profile →

Who can join

Adults 18 to 55, female only, with Provoked Vestibulodynia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life, and consequently negatively affects quality of life. Low intensity shock wave therapy produces physical forces that lead to pain relief. Aim: To evaluate the feasibility, safety and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia. Methods: A double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJ/〖mm〗\^2 ) using the "Medispec ED-1000®" shock wave generator or sham.

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 Provoked Vestibulodynia

Currently open trials in the same condition.

NCT07486830 — IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction · Phase 2 · recruiting
NCT07257029 — Topical Ketotifen 0.25% for Secondary Vestibulodynia · Phase 2 · recruiting
NCT05909514 — Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia · NA · active not recruiting

Other Rambam Health Care Campus trials

Trials by the same sponsor.

NCT07384013 — Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs · NA · recruiting
NCT06688253 — Intravenous Human IgG1 Fc Fragment (Efgartigimod) in Myasthenic Crisis · Phase 4 · not yet recruiting
NCT06235749 — Administration Of Calcium Gluconate for The Reduction of Blood Loss During Elective Cesarean Delivery · NA · recruiting
NCT06622902 — Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants. · NA · recruiting
NCT05922111 — Cervical Ripening Balloon for 12 Hours vs. 1 Hour. · NA · not yet recruiting

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 NCT04545255 (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 Rambam Health Care Campus
Last refreshed: 10 September 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/NCT04545255.

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