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Decreased Sexual
Desire-Naturally or Surgically Menopausal Women
SUMMARY: A medical
research study is underway for women who are concerned about their decreased
sexual desire. For many women, decreased sexual desire is often an
unfortunate consequence of menopause and can lead to feelings of
unhappiness, concern and frustration and can impact a woman’s relationship
with her partner. Hypoactive Sexual Desire Disorder (HSDD) is the most
common form of female dysfunction. The condition is typically identified by
decreased or absent sexual fantasies and desire for sex – and the exact
cause is unknown.
STUDY DESCRIPTION: The study will help evaluate the long-term safety
and efficacy of daily topical applications of LibiGel, an investigational
drug, compared to placebo gel (an inactive substance) in the treatment of
Hypoactive Sexual Desire Disorder in postmenopausal women. The study
consists of a screening period of up to 4 weeks and a 60-month treatment
period. Subjects will complete 9 office visits and 5 telephone contacts
during the course of the study. Also, the study will follow subjects for
heart blood vessel disease events and breast cancers for up to 5 years.
Inclusion Criteria:
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Natural menopausal women
50 years of age or older with a diagnosis of HSDD
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Subjects with hysterectomy
only must meet following menopause criteria: 50 to 54 years must be
experiencing hot flushes or receiving estrogen therapy for hot flashes
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At least one risk factor
for heart blood vessel disease including: 70 years or greater, type 2
diabetes, high blood pressure, smoking, or taking medication to treat
high blood pressure
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Agrees to provide research
site with contact information throughout the study period, which will
last up to 5 years
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Additional inclusion and
exclusion criteria apply and will be reviewed with you.
Disclosure/Rights
Before participating in a study, the study is explained to you in detail,
including the advantages and the side effects of each medication and your
time commitment. You are also given a detailed consent form to read. If you
desire, Coastal Connecticut Research will notify any of your physicians
about your participation.
During the course of the study, Dr. Spitz and his staff are always available
to answer any questions. Your privacy is protected, and your medical records
are confidential. You are free to discontinue the study at any time for any
reason.
For more information, please contact Carolyn at Coastal Connecticut Research
In New London, CT (860) 443-4567. All clinicians are board certified
gynecologists and nurse practioners.
For more information about this Study please contact Nicole, Carolyn or
Diane, Research Staff at:
Coastal Connecticut Research, LLC
342 Montauk Avenue
New London, CT 06320
Phone: (860) 443-4567
Toll Free: 1 (888) 437-7092
EMail: ccrvolunteer@gmail.com
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