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NCT03801031
Sexual Dysfunction in Gynecologic Oncology Patients
Phase 4 trial testing Lidocaine Topical in Gynecologic Cancer in 4 participants. Terminated before completion.
3 November 2021
Quick facts
| Lead sponsor | David Bender |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 4 |
| Start date | 6 June 2019 |
| Primary completion | 3 November 2021 |
| Estimated completion | 3 November 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lidocaine Topical — full drug profile →
- Placebo
Conditions studied
- Gynecologic Cancer — all drugs for Gynecologic Cancer →
- Sexual Dysfunction — all drugs for Sexual Dysfunction →
Sponsor
David Bender
Who can join
Adults 18 to 99, female only, with Gynecologic Cancer or Sexual Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This project will evaluate sexual dysfunction in women who have had surgery for gynecologic cancer. The subjects will complete a set of questionnaires about health, daily living, sexual encounters, and pain before their surgery and three times following. Each subject will be randomized to receive either lidocaine or a placebo that is applied vaginally immediately prior to any sexual encounters for approximately 6 months while maintaining a journal of sexual encounters and pain. The subjects and healthcare providers will be blinded to the treatment randomization until intervention and data collection is complete. Total participation will last up to one year from the date of enrollment. Subjects will visit the clinic at the same time as regular cancer care visits, receive the blinded intervention and complete the surveys.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03801031
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lidocaine Topical
Trials testing the same drug.
- NCT03206320 — Topical Lidocaine for Needle Insertion and Injection Pain · NA · completed
Other recruiting trials for Gynecologic Cancer
Currently open trials in the same condition.
- NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
- NCT07408349 — Guided Imagery of the Gynecological Cancer · NA · recruiting
- NCT07447050 — Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial · Phase 2 · recruiting
- NCT07173101 — Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairm · Phase 2 · recruiting
- NCT07166042 — Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies · Phase 3 · 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 NCT03801031 (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 David Bender
- Last refreshed: 6 December 2022
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/NCT03801031.
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