Progesterone and Resting Energy Expenditure

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates the effect of micronized progesterone substitution in the luteal phase on resting energy expenditure in women during menopausal transition.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Progesterone

Criteria

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.