Efficacy of Gynodian® Depot in Women With Impaired Well-being
Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
Participant gender:
Summary
The typical menopausal symptoms that are associated with a variety of physical and
psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired
sexual interest and enjoyment are caused by a lack of estrogen, a female sex hormone produced
inside the body. To treat these symptoms, women who are postmenopausal can receive a therapy
called 'hormone replacement therapy' (the dosage of hormones to replace the body's deficient
hormones), for instance, with estrogen preparations injected into a muscle.In women with a
uterus estrogen use causes the lining of the womb (endometrium) to grow (thicken) as before
the menopause. With long-term use this may lead to pathological changes of the endometrium.
That is why this therapy should be complemented by the estrogens' natural counterbalance,
progesterone (progestogen), at a certain interval. This causes the lining of the womb to
shed, with monthly bleeding like a normal period, thus avoiding excessive endometrial
growth.Estrogen treatment is well known to relieve psychological complaints. The combination
of an estrogen with a weak androgen (in this case Dehydroepiandrosterone (DHEA)) is presumed
to clearly increase this effect. The present clinical study is to prove that Gynodian? Depot
as a combination of estrogen and androgen has a better effect on psychological complaints and
sexuality in postmenopausal women than has treatment with the estrogen Estradiol valerate
alone.All patients will receive the same therapy, but differing in sequence. Either they
receive Gynodian? Depot during the first five cycles and the estrogen-only preparation during
cycles 6-10 (treatment group 1) or they receive the study medication in reverse order
(treatment group 2). Patients will be assigned to one of the two groups at random. In either
case they will be given an injection into the gluteal muscle every four weeks.Women with an
intact uterus, in addition to the injections (the day of the injection being the 1st day of a
cycle) have to take a tablet containing 5 mg Medroxyprogesterone acetate (MPA) (progestogen)
per day for 14 days (cycle days 15-28) to enable the endometrium to shed in a monthly
period.The study will extend over a total period of about 11 months, during which the patient
will have 16 appointments for examinations.After patient has signed on the informed consent
form for participation in this clinical study, the investigator will ask her, which diseases
she has at the moment or has had during the past 12 months and which medicinal products she
has been taking. Subsequently, she will have a gynecological examination (including the
breasts) as well as a general physical examination. Blood pressure, heart rate as well as
body height and weight will be measured and noted down. In addition, the doctor will question
her about physical and psychological menopausal complaints by means of two different, short
questionnaires. Only if the evaluation of these two questionnaires shows that she is eligible
for the participation in this clinical study, will the following actions be carried
through.Approx. 40 ml blood will be taken from the patient for a thorough laboratory test
including her hormone levels, and she will be asked for a urine sample. Additionally, she
will have a vaginal ultrasound examination of the womb lining, a cervical smear test (unless
already done during the last three months), and an x-ray examination of the breasts
(mammography) (unless already done during the last 12 months).These measures will be repeated
at Final visit.About 3 weeks after visit 1, when the investigator has the results of all
tests prescribed at visit 1, the patient will be asked to appear for visit 2.If the patient
is eligible for a participation in this clinical study, she will be given the first injection
of the study medication.During the following visits, injections will be given, blood pressure
and pulse rate as well as body weight will be measured and blood will be drawn to measure the
hormone levels.All procedures will apply also during the second treatment period. When
switching to the second treatment period a physical and gynecological examination will
additionally be performed.Questionnaires have to be filled in by the patient at different
time points during the study.
Phase:
Phase 3
Details
Lead Sponsor:
Bayer
Collaborators:
Ecron Acunova GmbH LKF Laboratory Navitas Life Sciences GmbH