The primary objective is to evaluate health related QoL under an oral sequential treatment with natural steroid hormones: Duogestan®. The secondary objective is to evaluate the bleeding patterns over a one-year period.
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Health related QoL will be assessed by the Dutch validated versions of the
Women*s Health Questionnaire (WHQ) and the European Quality of life instrument
(EuroQol).
Secondary outcome
Bleeding patterns will be assessed by a bleeding-diary.
Background summary
The menopausal transition and the menopause are responsible for important
quality of life (QoL) and preventive health challenges. Different publications
show that hormone replacement therapy (HRT) improves quality of life through
the reduction of both the number and severity of menopausal symptoms. This
study differs from previous studies (using synthetic progestins, such as used
in the Women*s Health Initiative study) by the addition of micronised natural
progesterone to estradiol in a low dose regimen.
Study objective
The primary objective is to evaluate health related QoL under an oral
sequential treatment with natural steroid hormones: Duogestan®. The secondary
objective is to evaluate the bleeding patterns over a one-year period.
Study design
A randomized (2/1 randomization), double-blind, placebo-controlled study.
Intervention
Each patient will receive 13 cycles of 28 days Duogestan® (1mg micronized 17 *-
E2, 200mg micronized progesterone (P4)) or 6 cycles placebo followed by 7
cycles Duogestan®, each cycle consisting of 25 days of treatment followed by 3
days free of treatment.
In case climacteric complaints of a patient persist after 3 months of
treatment, the patient will receive Clonidine® (a non-hormonal, FDA-approved
drug for treatment of hot flushes) to treat her symptoms.
After a treatment-period of 6 months, patient*s complaints and
risks/benefits-profile will be evaluated.
Study burden and risks
Each patient has to take Duogestan® or placebo during 13 cycles of 28 days (1
year). The number of site visits is six. During each visit the WHQ and EuroQol
will be completed. In between the site visits, the patients will keep a diary
for the registration of bleeding and treatment intake. Blood samples will be
taken three times. All patients will undergo a physical examination and a
vaginal ultrasound, as well as a progestagen (P) challenge test. If necessary,
endometrial biopsy will be performed. A mammography will be carried out if the
patient has not had a mammography before, or if the last mammography is dated
more than one year ago.
Risks associated with the study include possible risks of Duogestan® treatment
and possible side effects of blood drawing. Since HRT relieves symptoms of
menopause and therefore improves quality of life, patients might benefit from
treatment with Duogestan®.
Postbus 5800
6202 AZ Maastricht
Nederland
Postbus 5800
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
1. Postmenopausal women: last menstrual period between 6 months and maximum 2 years ago, FSH levels > 35 IU/L and estradiol levels < 20 picograms/mL (cut offs defined by central laboratory: *Klinisch Chemisch Laboratorium* at MUMC)
2. Endometrium thickness less than 5 mm
3. Negative progesterone challenge test
3. 4. Age between 45-55 years
5. Menopausal symptoms including at least moderate to severe vasomotor symptoms (defined as at least 35 moderate (sensation of heat with sweating, able to continue activity) to severe (sensation of heat with sweating, causing cessation of activity) hot flushes and/or night sweats per week
6. Intact uterus
7. Normal mammography within the last 12 months
8. Able to understand and sign informed consent form
Exclusion criteria
1. Previous use of any hormone replacement therapy; except the use of estriol or phyto-estrogens
2. BMI > 35
3. Use of oral contraceptives during the last 2 months
4. Use of hormonal intra uterine device or implant during the last 2 months
5. Known contra-indications for Duogestan®:
- Known, past or suspected breast cancer;
- Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer);
- Undiagnosed genital bleeding;
- Untreated endometrial hyperplasia;
- Previous idiopathic or current venous trhomboembolism (deep vein thrombosis, pulmonary embolism);
- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
- Acute liver disease or a history of liver disease, until liver function tests have returned to normal;
- Known hypersensitivity to the active substances or to any of the excipients;
- Porphyria
6. Use of medication known to interact with 17 ß-estradiol or micronized progesterone;
- Substances known to induce drug-metabolising enzymes, particularly anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, fifabutin, nevirapine, efavirenz)
- Ritonavir and nelfinavir
- Herbal preparations containing St. John*s Wort (Hypericum perforatum)
7. Participation in an investigational study within 30 days prior to administration of the study medication
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov in behandeling |
| EudraCT | EUCTR2008-008311-26-NL |
| CCMO | NL30326.068.09 |