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

This study has been terminated.
(Funding)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maire Mac Bride, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00816556
First received: December 30, 2008
Last updated: February 12, 2014
Last verified: February 2014
  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 valerate
Drug: Vanicream Lite
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.


Secondary Outcome Measures:
  • Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks [ Time Frame: baseline, 2 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks [ Time Frame: baseline, 2 weeks, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (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 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
Drug: Estradiol valerate
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
Other Name: Delestrogen
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
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816556

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Maire Mac Bride
Investigators
Principal Investigator: Maire B Mac Bride, MB BCh Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Maire Mac Bride, M.B., B. Ch., Assistant Professor of Medicine, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00816556     History of Changes
Other Study ID Numbers: 07-008730, UL1TR000135
Study First Received: December 30, 2008
Results First Received: February 12, 2014
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrophic Vaginitis
Vaginitis
Atrophy
Genital Diseases, Female
Pathological Conditions, Anatomical
Vaginal Diseases
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014