Menopause Clinical Trial
— P4&REEOfficial title:
Impact of Progesterone Substitution in Luteal Phase on Resting Energy Expenditure in Women During Menopausal Transition.
Verified date | March 2022 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effect of micronized progesterone substitution in the luteal phase on resting energy expenditure in women during menopausal transition.
Status | Terminated |
Enrollment | 2 |
Est. completion date | May 27, 2021 |
Est. primary completion date | May 27, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women during early menopausal transition (MT) with indication for luteal phase progesterone substitution (definition of early MT: change of cycle length (shorter or longer menstrual cycle) of at least = 7 days from normal and/or phases of amenorrhea of up to < 60 days during the preceding 12 months) - Body Mass Index (BMI) 18.5 - 24.9 kg/m2 - Informed Consent as documented by signature Exclusion Criteria: - Pregnancy or Lactation - Systemic hormone therapy or hormonal contraception (estradiol, progestogen, androgen) during the study and within 12 weeks prior to study entry - Phytotherapeutics for menstrual cycle regulation during the study and within 12 weeks prior to study entry - Active psychiatric disease - Use of psychotropic drugs during the study and within 12 weeks prior to study entry - Nicotin abuse > 10 cigarettes/day - Alcohol abuse - Use of appetite suppressants - Diabetes mellitus - Untreated Hypo- and hyperthyroidism - Hypersensitivity to progesterone - Hypersensitivity to sunflower oil, soy lecithin and other ingredients of Utrogestan® such as gelatine, glycerol, E171 (titanium dioxide) - Contraindication of progesterone medication according to swissmedicinfo.ch (suspected or diagnosed neoplasia of the breast or other sexual organ; benign or malignant liver Tumors (also in medical history); acute or chronic liver disease (Rotor- or Dubin-Johnson-Syndrome); cholestatic jaundice; porphyria; arterial or venous thromboembolic Events and cerebral bleedings; abnormal genital bleeding of unknown cause) - Use of barbiturates, antiepileptic drugs, tuberculostatic drugs, antiretroviral drugs, antimycotic drugs, antibiotic drugs, Hypericum perforatum and Spironolactone - Known or suspected non-compliance, drug or alcohol abuse etc. - Illiteracy - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern | Berne |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in resting energy expenditure | Change in resting energy expenditure (kcal/day) from cycle 1 due to substitution of Utrogestan in luteal phase | cycle 1 (day 20) to cycle 3 (day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in miRNA expression | Change in miRNA expression (miR-370, miR-29b) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in energy intake | Change in energy intake (kcal/day) | cycle 1 (day 17-19) and cycle 3 (day 17-19), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in body core temperature | Change in body core temperature (°C) | cycle 1-3 during luteal phase, (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in serum hormone profile FSH | Change in serum hormone profile: FSH (U/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in serum hormone profile LH | Change in serum hormone profile: LH (U/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in serum hormone profile estradiol | Change in serum hormone profile: estradiol (pmol/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20) | |
Secondary | Mean change in serum hormone profile progesterone | Change in serum hormone profile: progesterone (nmol/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in fasting glucose | Change in fasting glucose (mmol/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in fasting Insulin | Change in fasting Insulin (mU/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in blood lipid serum level: cholesterol | Change in cholesterol (mmol/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in blood lipid serum level: LDL | Change in LDL (mmol/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in blood lipid serum level: HDL | Change in HDL (mmol/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) | |
Secondary | Mean change in blood lipid serum level: triglycerides | Change in triglycerides (mmol/l) | cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days) |
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