Efficacy of Gynodian® Depot in Women With Impaired Well-being
Condition: Hormone Replacement Therapy
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Gynodian® Depot (BAY86-5032); BAY86-4980
Intervention type(s): Drug; Drug
Intervention description(s): Injection monthly; orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hormone Replacement Therapy; Impaired well-being, mood and sexuality