Last reviewed · How we verify
NCT03520426
Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
NA trial testing Votiva RF in Vaginal Atrophy in 50 participants. Status unknown.
30 January 2020
Quick facts
| Lead sponsor | Walden, Jennifer L., M.D.,P.L.L.C. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 12 March 2018 |
| Primary completion | 30 January 2020 |
| Estimated completion | 30 January 2020 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Votiva RF
Conditions studied
- Vaginal Atrophy — all drugs for Vaginal Atrophy →
- Vaginal Relaxation — all drugs for Vaginal Relaxation →
- Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
Sponsor
Walden, Jennifer L., M.D.,P.L.L.C.
Who can join
Adults 25 to 65, female only, with Vaginal Atrophy or Vaginal Relaxation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-site, randomized, prospective study designed to evaluate the safety and efficacy of the Votiva device headpieces through radiofrequency for vaginal rejuvenation. An anticipated 50 subjects will undergo 3 treatments of the vulvovaginal area using radiofrequency unit or radiofrequency placebo. Study duration for each subject is approximately six months (including screening, 3 treatment sessions 3-4 weeks apart and 2 follow-up visit at 3 and 6 months post initiation of treatment (4 and 12 weeks after completion of last treatment). Efficacy will be measured and evaluated by validated questionnaires to include: The Vulvovaginal Symptoms Questionnaire, Vaginal Laxity Questionnaire (VLQ), Urogenital Distress Short Form (UDI-6) and Incontinence Impact Questionnaire Short Form (IIQ-7), Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03520426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vaginal Atrophy
Currently open trials in the same condition.
- NCT05457972 — Postpartum Vaginal Estrogen for Breastfeeding Patients · Phase 4 · recruiting
- NCT06028009 — PRP Injections for Genitourinary Syndrome of Menopause · NA · active not recruiting
- NCT07024667 — Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vagin · NA · recruiting
- NCT05335317 — Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser · NA · recruiting
- NCT04807894 — Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03520426 (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 Walden, Jennifer L., M.D.,P.L.L.C.
- Last refreshed: 9 May 2018
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/NCT03520426.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing