Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors

PRIMARY OBJECTIVES:

I. To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with
vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal
laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS).

SECONDARY OBJECTIVES:

I. To evaluate toxicity associated with vaginal laser therapy in this population.

II. To determine how many women with the defined patient eligibility will complete all
treatments.

III. To determine the feasibility of the crossover design for potential use in a phase III
trial.

IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser
therapy versus sham treatment.

V. To determine improvement in sexual function as measured by Female Sexual Function Index
(FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and
behavior with vaginal laser therapy versus sham treatment.

VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser
therapy versus sham treatment using the Urogenital Distress Inventory (UDI).

VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy.

OUTLINE: Patients are randomized in to 1 of 2 arms.

ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.

ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then
crossover to Arm I.

After completion of study, patients are followed up at 1 month.

Inclusion Criteria:

- Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed
all cancer related treatment >= 6 months prior to enrollment

- Any form of hysterectomy, including radical hysterectomy permitted

- Must have no evidence of recurrent disease on pelvic exam within past 3 months

- Radiation therapy is permitted but not required

- Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale
from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the
inability to be sexually active due to pain

Exclusion Criteria:

- Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or
ovarian cancer

- Pelvic organ prolapse stage II or higher

- Prior reconstructive pelvic surgery involving mesh

- Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to
enrollment