We are no longer recruiting volunteers for this particular study.  Please call our office at (860) 443-4567, for information about similar upcoming clinical research studies

Clinical Research Trial for Post-menopausal Women

with Vaginal Atrophy

The following is an overview of this clinical trial and is intended to provide prospective patients with information that may help them decide whether to consider participating in the trial. Please note that there are additional details regarding inclusion/exclusion criteria, and details important to making a final decision regarding participating that are not listed on this page. These will be discussed in person by a member of Coastal Connecticut Research, and all relevant information will be provided in the Informed Consent Form that must be read by the prospective participant.

Summary:

Up to 40% of post-menopausal women experience symptoms of vaginal atrophy, including vaginal dryness, vaginal soreness, vaginal burning or pain during intercourse. Traditional treatments have been mainly the use of vaginal lubricants or estrogen. This research study is to test an investigational medication as an alternative to estrogen to see if it helps this condition.

Study Medication:

The investigational medication being used in this trial is being evaluated in multiple areas to determine if it has benefit for the post-menopausal woman. You may, however, receive no direct benefit from participation in this study.

Basic Eligibility Requirements: 

• 50-80 years of age
• Must be at least 3 years post-menopausal with no vaginal bleeding or spotting in the past year
• Must not have used hormone, estrogen or progesterone replacement, Evista, or Tamoxifen within 2 months prior to entering this study. Certain other medications may also exclude participation.
• Must not have a history of superficial or deep vein thrombosis, and must not have any condition requiring anticoagulant therapy
• Must not have a history of cancer within the past 5 years, with the exception of basal cell or squamous cancer of the skin that has been removed by surgery.
• Must not have lichen sclerosis, or a history of precancerous changes of the vulva or vagina

• Must not be having more than mild hot flashes

Testing provided at no charge: 

• Bone Mineral Density testing (DEXA) of the hip and spine, unless one has been performed within the past 12 months.
• Mammogram, unless one has been done within the past 9 months.
• EKG.
Pap smear, lab work and study-related physical exam at Coastal Connecticut Research office.

Compensation:

• Up to $50 per visit, beginning with the baseline visit when medication is first given.

All information collected from patients is kept confidential. It will be made available to the sponsor of this study and to the FDA. We are also happy to share all test results with your primary physician.