Clinical Trials

A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

Location:

Trial status:

Inactive

Why is this study being done?

This trial will measure the effects of very low doses of estradiol or estriol cream applied to the vaginal introitus for the treatment of atrophic vaginitis, a common condition affecting up to 40% of postmenopausal women. We will conduct a randomized controlled trial with three arms-estradiol, estriol and placebo. The intervention will last for 12 weeks. The outcomes we will be most interested in are the efficacy of the treatments for symptoms of atrophic vaginitis compared to placebo and whether there is any measurable systemic absorption from the locally applied estrogen creams. These outcomes will be measured, primarily, by the use of patient questionnaires and secondarily, clinical examination scores. Safety will be evaluated with serum estrogen concentrations. All measures will be collected at baseline and at the termination of the study. Hormone concentrations will be collected, additionally, at week 2. This trial will answer important questions regarding the impact of very low doses of locally applied estrogens and symptoms of atrophic vaginitis. It will provide information on effect size and validity of outcome measures. It will also give information about whether low doses of estrogen creams, locally applied to the vaginal introitus, result in systemic absorption

Who is eligible to participate?

Inclusion Criteria:

- postmenopausal women (no menses for the previous 12 months)

- aged 40 through 75

- dryness, itching or burning in and around the vagina

- discontinued HT (either local or systemic) at least 3 months

Exclusion Criteria:

- Known, suspected, or history of cancer of the breast.

- Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).

- Known hypersensitivity to any component of the medications or base creams.

- Active deep vein thrombosis, pulmonary embolism, or history of these conditions.

- Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).

- Liver dysfunction or disease with elevation of AST>1.5x ULN Normal for females is 8-43 U/L.

- Undiagnosed abnormal genital bleeding.

- Known chronic lichen sclerosis.

- Known, untreated vaginal infection.

- Not had a normal screening mammogram within the last 15 months.

- Hysterectomy without oophorectomy unless 60 years or older.

- Women taking aromatase inhibitors or tamoxifen.

- Hgb <12.0 or >15.5 g/dL

- Urinalysis showing a urinary tract infection (UTI).

Last updated: 03/05/2013

NCT ID:

NCT00816556