-
treatment of moderate to
severe vasomotor symptoms (e.g. hot flashes, cold flashes, night sweats)
associated with menopause.
-
prevention of osteoporosis.
-
treatment of vulvar and
vaginal atrophy (a major cause of vaginal dryness, soreness, burning, or
pain with intercourse).
-
In addition, the results of
number of observational studies have suggested that estrogen replacement
therapy is associated with reduced cardiovascular morbidity.
There has been considerable media attention recently concerning the pros,
and more particularly the cons, of HRT. At Coastal Connecticut Research we
would be happy to discuss these issues with you prior to your decision
whether to participate in this trial.
Study Medication:
-
17ß-estradiol (an estrogen)
and progesterone.
-
Many forms of estrogen and
progestins are currently available for hormone replacement therapy. The
estrogen and progesterone in this study medication are formulated to be
identical to the estrogen and progesterone produced by a woman’s ovaries
before menopause.
-
There will be three different
treatment groups. All women will receive 1mg daily of estradiol. The groups
will differ in the amount of progesterone that is combined with the
estrogen.
Basic Eligibility Requirements:
-
Women between age 40 and 70
with an intact uterus.
-
Menopausal, either naturally
or due to removal of both ovaries, with no period for at least 6 months
prior to starting the study.
-
No use of oral estrogen for 2
months prior to start of study, and no use of transdermal estrogen for 1
month.
-
No history of cancer (except
basal cell carcinoma in remission for at least 6 months).
-
No history of mammogram report
suspicious for malignancy.
-
No history of phlebitis, deep
vein thrombosis (DVT), pulmonary embolus, or stroke.
Required testing:
-
Mammogram within 3 months
prior to starting the study.
-
Transvaginal ultrasound,
endometrial biopsy, Pap smear, lab work and physical exam at Coastal
Connecticut Research office at the beginning and end of the study. These are
provided free of charge.
-
Menopause specific quality of
life questionnaire will be administered.
Randomization:
-
Following successful screening
there will be a baseline visit at which time each participant will be
assigned at random to one of the three treatment groups.
-
There is no placebo group –
all women receive hormone replacement therapy.
-
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.
Duration of study:
-
1 year
-
Following successful
screening, a baseline visit when medication is first dispensed, plus 6
follow-up visits are required.
Compensation:
-
$125 for the screening visit
in which ultrasound, exam and endometrial biopsy are performed, $125 for the
final visit, and $50 per visit for the baseline visit and each of the 5
follow up visits prior to the final visit.
Compliance with Good Clinical Practice and ethical considerations:
This study will be conducted in accordance with Good Clinical Practice as
contained in the U.S. Code of Federal Regulations governing the protection
of human subjects (Title 21, Part 50), IRBs (Title 21, Part 56) and the
obligations of clinical investigators (Title 21, Part 312). This study will
also be conducted in accordance with the Declaration of Helsinki, including
the latest amendments
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 read by the prospective
participant.
