A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Condition: Atrophic Vaginitis
MeSH terms: Vaginitis; Atrophic Vaginitis; Atrophy
Intervention: Estriol; Estradiol valerate; Vanicream Lite
Intervention description: Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for 2 weeks and then twice weekly for 10 weeks.; Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks; Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: Female
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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).