A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrophic Vaginitis |
Drug: estriol Drug: estradiol Drug: Vanicream Lite |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis |
- 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To evaluate the systemic absorption of 10 micrograms of estradiol and 10 micrograms of estriol cream applied topically to the vaginal introitus twice weekly. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: estriol
estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
|
Drug: estriol
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
|
|
Active Comparator: estradiol
estradiol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
|
Drug: estradiol
estradiol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
|
|
Placebo Comparator: Vanicream Lite
Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
|
Drug: Vanicream Lite
Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
|
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| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Maire Brid Mac Bride MB BCh, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00816556 History of Changes |
| Other Study ID Numbers: | 07-008730 |
| Study First Received: | December 30, 2008 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Vaginitis Atrophy Vaginal Diseases Genital Diseases, Female Pathological Conditions, Anatomical Estradiol Polyestradiol phosphate Estrogens Estradiol valerate Estradiol 3-benzoate |
Estradiol 17 beta-cypionate Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 22, 2013