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4% Topical Lidocaine Gel for Painful Intercourse (BCLS Trial)

N/A
Waitlist Available
Led By James L Whiteside, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects included must be female breast cancer survivors over the age of 18, sexually active (at least 4 episodes of sexual intercourse per month), and find intercourse painful. Subjects must also be English speaking and able to give informed consent.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

BCLS Trial Summary

This trial is testing whether CO2 laser therapy or lidocaine applied to the vagina before sex is more effective in reducing pain during sex for breast cancer survivors.

BCLS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BCLS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breast
Secondary outcome measures
3 Incontinence Questions (3-IQ) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
Colon Rectal Anal Distress Inventory (CRADI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
Breast
+4 more
Other outcome measures
Symptom inventory (number of voids/day, pads/day, etc.)

BCLS Trial Design

2Treatment groups
Active Control
Group I: 4% Topical Lidocaine GelActive Control1 Intervention
This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).
Group II: CO2RE LaserActive Control1 Intervention
This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
427 Previous Clinical Trials
634,292 Total Patients Enrolled
Syneron CandelaIndustry Sponsor
2 Previous Clinical Trials
46 Total Patients Enrolled
James L Whiteside, MDPrincipal InvestigatorUniversity of Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Sex & Marital TherapyJournal
The Female Sexual Function Index (FSFI): A Multidimensional Self-report Instrument for the Assessment of Female Sexual Function
Rosen, C. Brown, J. Heiman, S. Leib, R.. 2000. “The Female Sexual Function Index (FSFI): A Multidimensional Self-report Instrument for the Assessment of Female Sexual Function”. Journal of Sex & Marital Therapy. Informa UK Limited. doi:10.1080/009262300278597.
CA: A Cancer Journal for CliniciansJournal
Cancer Treatment and Survivorship Statistics, 2016
Miller, Kimberly D., Rebecca L. Siegel, Chun Chieh Lin, Angela B. Mariotto, Joan L. Kramer, Julia H. Rowland, Kevin D. Stein, Rick Alteri, and Ahmedin Jemal. 2016. “Cancer Treatment and Survivorship Statistics, 2016”. CA: A Cancer Journal for Clinicians. Wiley. doi:10.3322/caac.21349.
Lasers in Medical ScienceJournal
Microscopic and Ultrastructural Modifications of Postmenopausal Atrophic Vaginal Mucosa After Fractional Carbon Dioxide Laser Treatment
Zerbinati, Nicola, Maurizio Serati, Massimo Origoni, Massimo Candiani, Tommaso Iannitti, Stefano Salvatore, Francesco Marotta, and Alberto Calligaro. 2014. “Microscopic and Ultrastructural Modifications of Postmenopausal Atrophic Vaginal Mucosa After Fractional Carbon Dioxide Laser Treatment”. Lasers in Medical Science. Springer Science and Business Media LLC. doi:10.1007/s10103-014-1677-2.
clinicaltrials.govStudy
Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors
James Whiteside 2018. "Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03257670.
All > Dyspareunia
~10 spots leftby Apr 2025
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