A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrophic Vaginitis
Intervention: estriol (Drug); estradiol (Drug); Vanicream Lite (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Maire B Mac Bride, MB BCh, Principal Investigator, Affiliation: Mayo Clinic
Overall contact:
Maire B Mac Bride, MB BCh, Phone: 507-284-2511, Email: macbride.maire@mayo.edu
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.
Clinical Details
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To determine whether low dose estrogen (10 mcg of estradiol cream or 10 mcg of estriol cream) applied topically twice weekly to the vaginal introitus in postmenopausal women with atrophic vaginitis (AV) relieves the severity symptoms of AV.
Secondary outcome: To evaluate the systemic absorption of 10 micrograms of estradiol and 10 micrograms of estriol cream applied topically to the vaginal introitus twice weekly.
Detailed description:
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
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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).
Locations and Contacts
Maire B Mac Bride, MB BCh, Phone: 507-284-2511, Email: macbride.maire@mayo.edu
Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Maire B Mac Bride, MB BCh, Phone: 507-284-2511, Email: macbride.maire@mayo.edu
Deborah J Rhodes, MD, Phone: 507-284-2511, Email: rhodes.deborah@mayo.edu
Maire B Mac Bride, MB BCh, Principal Investigator
Debra L Barton, Ph D, Sub-Investigator
Deborah J Rhodes, MD, Principal Investigator
Lynne T Shuster, MD, Sub-Investigator
Brandon R Grossard, MS, Sub-Investigator
Additional Information
Mayo Clinic Clinical Trials
Starting date: October 2008
Ending date: December 2010
Last updated: September 17, 2009
|
