Clinical Trial for Post-menopausal Women
with Decreased Sexual Arousal


This is one of a pair of studies on post-menopausal changes in sexual function. This study is focused on women who maintain a desire and interest in having sexual activity, but who are experiencing decreased response in an intimate situation, possibly with difficulty reaching orgasm.

The paired study focuses on women who are primarily experiencing a decrease in their level of desire for sexual activity that began during, or after, their menopause.

Women participating in both studies should be maintaining some level of regular sexual activity (for example once a month or more often), despite lesser satisfaction than in younger years.


Study Medication:

This is a study of an investigational medication that is currently being tested for multiple potential benefits for post-menopausal women including:

Ø Improving decreased post-menopausal sexual desire
Ø Improving decreased post-menopausal sexual arousal
Ø Prevention of bone loss and osteoporotic fractures
Ø Decreasing the incidence of hormone-sensitive breast cancer
Ø Lowering serum cholesterol


Basic Eligibility Requirements:

Ø Minimum age 48.
Ø Must be at least 3 years post-menopausal.
Ø Must be sexually active at least once a month on average, even if the sexual activity may not be fully satisfying.
Ø Must not currently be using estrogen replacement, Evista, Tamoxifen, Wellbutrin or treatments for sexual dysfunction. (Various time intervals are required between ending such treatment and participating in this trial.)
Ø May have mild, but not severe, pain with intercourse (mild pain, for example, might be relieved with lubricants).
Ø Must not have a history of superficial or deep vein thrombosis.

Required testing:

Ø Mammogram within 6 months prior to starting the study.
Ø Sexual function questionnaire and interview at Coastal Connecticut Research office. This process will help determine whether a patient is better suited for this trial, or for our trial on decreased libido.
Ø EKG, Pap smear, lab work and physical exam at Coastal Connecticut Research office. These are provided free of charge.
Ø Patients will be required to maintain a diary during the entire course of the study.

Randomization:

Ø Following successful screening there will be a baseline visit at which time each participant will be assigned at random to one of three study groups. Two of the groups will receive the study medication, but at different doses. The third group will receive a placebo. There is a 1/3 chance of being assigned to any group.
Ø This is a double-blind trial, so neither the patient, nor the members of Coastal Connecticut Research will know to which group the patient has been assigned. There is always a sealed record that can be opened in an emergency to determine whether the patient is receiving the investigational treatment.

Duration of study:

Ø 6 visits over 1 year following the baseline visit when medication is first given.

Compensation:

Ø $30 per visit, beginning with the baseline visit when medication is first given. With successful completion of the study this totals $180 for 6 visits.

Potential Side effects:

In clinical trials conducted to date, the study medication has been generally well tolerated. The following are felt to be the most significant potential side effects:

Ø Leg cramps
Ø Thrombophlebitis
Ø Hot flashes

All information collected from patients is kept strictly confidential. While all study information from participating women will be made available to the sponsor of this study and to the FDA, in all but rare cases (for example, an audit or investigation) your identity will remain unknown to them and to others connected with this study. We are happy to share all test results with your primary physician.

Please note:

The preceding 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. 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 with interested participants in person by a member of Coastal Connecticut Research, and all relevant information will be provided in the Informed Consent Form that must be reviewed by the prospective participant.

At Coastal Connecticut Research, we are excited about the possibilities for this investigational medication, and hope that you will consider joining us in this trial.