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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause pain with intercourse. Other symptoms can include urinary frequency and urinary urgency. These symptoms are caused by the decreasing levels of estrogens in postmenopausal women.

The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at the lowest dose for the shortest time. We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream.

We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a placebo cream. Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and is only available at compounding pharmacies. We want to see if either of these estrogens is effective at one tenth the usual dose. We also want to see if these creams are effective when massaged onto the outer part of the vagina, rather than the usual method of treatment, which is inserting them into the vagina.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maire Mac Bride
• Collaborator: National Center for Advancing Translational Science (NCATS)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal women (no menses for the previous 12 months)

• Dryness, itching or burning in and around the vagina

• Discontinued hormone replacement therapy (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 aspartate aminotransferase (AST)>1.5x upper level of normal (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).