Trial Search Results

Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

The Cleveland Clinic

Collaborator: Foundation for Female Health Awareness

Stanford Investigator(s):

Intervention(s):

  • Device: CO2 fractionated vaginal laser
  • Drug: Estrogens, Conjugated (USP)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Menopausal with absence of menstruation for at least 12 months

   - Presence of vaginal atrophy symptoms [subjective assessment of vaginal dryness >7cm on
   VAS)

   - Prolapse stage < II, according to the pelvic organ prolapse quantification (POP-Q)
   system[31]

   - No pelvic surgery within 6 months prior to treatment (vulva biopsy may be included
   after 2 weeks)

   - Understanding and acceptance of the obligation to return for all scheduled follow-up
   visits

Exclusion Criteria:

   - Personal history of vulvovaginal condyloma,,vaginal intraepithelial neoplasia (VAIN),
   vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation,
   history of cervical cancer, other gynecologic cancer, or pelvic radiation

   - Acute or recurrent urinary tract infection (UTI), or genital infection (e.g.
   bacterial; vaginosis, herpes genitalis, candida).

   - Personal history of Scleroderma

   - Any serious disease, or chronic condition, that could interfere with the study
   compliance

   - Previously undergone reconstructive pelvic surgery within the past 6 months

   - Previously undergone reconstructive pelvic surgery with transvaginal mesh kits and
   sacrocolpopexy with synthetic mesh for prolapse, excluding synthetic slings (unless
   current untreated exposure or extrusion)

   - Have used vaginal estrogen cream, ring or tablet within 1 month prior to entering the
   study

   - Vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy

   - Personal history of thrombophlebitis

   - Personal history of heart failure or myocardial infarction within 12 months of
   procedure

   - Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin
   E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment

   - Taking medications that are photosensitive

   - Contraindication to Vaginal Estrogen Therapy

   - Unwilling to Take Vaginal Estrogen

   - Inability to give informed consent

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Eric Sokol, M.D.
Recruiting