Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- History of breast cancer (currently no evidence of disease)

- Unwilling to take vaginal estrogen due to fear of an increased risk of breast
cancer

- Significant vaginal complaints, defined as persistent vaginal dryness and/or itching
of sufficient severity to make a patient desire therapeutic intervention

- Symptoms present ≥ 2 months prior to randomization

- No active vaginal infection

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Female

- Postmenopausal or no childbearing potential

- Life expectancy > 6 months

- SGOT < 1.5 times upper limit of normal (ULN) for the past year

- Creatinine ≤ 1.5 times ULN for the past year

- Able to complete questionnaire(s) alone or with assistance

- No diagnosis of any of the following:

- Asthma

- Chronic obstructive pulmonary disease

- Coronary artery disease

- Narrow angle glaucoma

- Known cholelithiasis

- Vulvar and vaginal dysplasia

- Essential vulvodynia

- Vulvar vestibulitis

- Vaginal prolapse

- Bartholin cyst/abscess

- Lichen sclerosis

- Lichen planus of the vulvovaginal region

- Desquamative vaginitis

- No known history of cardiac arrhythmia

- No history of Bartholin gland surgery

- No acute iritis

PRIOR CONCURRENT THERAPY:

- No initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months
prior to study randomization or plans to initiate or discontinue any of these
medications during the 6-week study period

- More than 1 week since prior vaginal preparations*

- If patient has used vaginal preparations during the previous week but is
planning to stop, then the patient may enter the study with plans to start with
pretreatment questionnaire 1 week later NOTE: *Lubricants used during sexual
intercourse are allowed

- No prior radical pelvic surgery

- Total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH/BSO)
allowed

- No prior pilocarpine hydrochloride

- No prior or concurrent pelvic radiotherapy

- More than 4 weeks since prior and no concurrent estrogen products

- No concurrent vaginal preparations (including any over-the-counter or herbal
preparations)

- No other concurrent anticholinergics

- No concurrent chemotherapy

- No concurrent hormonal therapy, including progestationally-coated intrauterine
devices (IUDs)

- No concurrent pharmacologic soy preparations

- No concurrent surgery and/or radiotherapy for recurrent cancer

- No beta adrenergic antagonists

- No other concurrent treatment for vaginal dryness