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

Phase 3
18 Years
Not Enrolling
Breast Cancer, Sexual Dysfunction, Sexuality and Reproductive Issues

Thank you

Trial Information

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



- Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal
dryness in patients with breast cancer.


- Evaluate any toxicities arising from pilocarpine hydrochloride in these patients.

- Evaluate quality of life of these patients treated with pilocarpine hydrochloride.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs > 65), concurrent
tamoxifen therapy (yes vs no vs unknown [e.g., on a blinded clinical study]), concurrent
aromatase inhibitor therapy (yes vs no vs unknown [e.g., on a blinded clinical study]), and
perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe).
Patients are randomized to 1 of 4 treatment arms.

- Arm I: Patients receive oral pilocarpine hydrochloride once a day for 3 days, twice a
day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks
in the absence of unacceptable toxicity.

- Arm II: Patients receive oral pilocarpine hydrochloride once a day for 3 days and then
twice a day for up to 6 weeks in the absence of unacceptable toxicity.

- Arm III: Patients receive oral placebo once a day for 3 days, twice a day for 3 days,
three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence
of unacceptable toxicity.

- Arm IV: Patients receive oral placebo once a day for 3 days and then twice a day for up
to 6 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and then weekly for 6 weeks.

PROJECTED ACCRUAL: A total of 192 patients will be accrued for this study.

Inclusion Criteria


- 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

- 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


- 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


- 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)

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:


Safety Issue:


Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
  • sexuality and reproductive issues
  • sexual dysfunction
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms
  • Sexual Dysfunctions, Psychological



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