Safety of oral micronized progesterone versus norethisterone acetate in continuous combination with oral estrogen as menopausal hormone therapy – a double-blind randomized study- PROBES study (Progesterone Breast Endometrial Safety study)

Conditions

Climacteric symptoms

Brief summary

Percentage change in mammographic density compared between the groups.

Detailed description

Incidence of endometrial proliferation (proliferation marker (Ki67), Endometrial thickness on ultrasound, Bleeding pattern as documented in a bleeding diary, Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue, Depression and anxiety symptoms (Patient Health Questionnaire (PHQ-9), Hospital Anxiety and Depression Scale (HADS)), Health-related quality of life (Psychological General Well-Being Index (PGWB)), Women’s Health Questionnaire (WHQ), Blood lipid profile, serum hormones, growth and metabolic factors (follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, sex hormone-binding globulin, IGF–I and its binding proteins), and coagulation factors (antitrombin, factor V Leiden, factor II mutation, cardiolipin-ab, Lupus anticoagulant, Protein C activity, Protein S free, APT-time, fibrinogen, prothrombin complex, thrombocytes).

Related papers

No related papers found yet.

Interventions

DRUGUtrogestan 200 mg mjuk vaginalkapsel

DRUGEstrofem 1 mg filmovertrukne tabletter

DRUGPharmaceutical form: Capsule Route of administration: Oral use Which IMS is it a placebo for?: Utrogestan Is it otherwise identival tio the IMP?: Yes

DRUGActivelle 1 mg/0

DRUG5 mg filmdragerade tabletter

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Percentage change in mammographic density compared between the groups.	—

Secondary

Measure	Time frame
Incidence of endometrial proliferation (proliferation marker (Ki67), Endometrial thickness on ultrasound, Bleeding pattern as documented in a bleeding diary, Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue, Depression and anxiety symptoms (Patient Health Questionnaire (PHQ-9), Hospital Anxiety and Depression Scale (HADS)), Health-related quality of life (Psychological General Well-Being Index (PGWB)), Women’s Health Questionnaire (WHQ), Blood lipid profile, serum hormones, growth and metabolic factors (follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, sex hormone-binding globulin, IGF–I and its binding proteins), and coagulation factors (antitrombin, factor V Leiden, factor II mutation, cardiolipin-ab, Lupus anticoagulant, Protein C activity, Protein S free, APT-time, fibrinogen, prothrombin complex, thrombocytes).	—

Measure

Time frame

Incidence of endometrial proliferation (proliferation marker (Ki67), Endometrial thickness on ultrasound, Bleeding pattern as documented in a bleeding diary, Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue, Depression and anxiety symptoms (Patient Health Questionnaire (PHQ-9), Hospital Anxiety and Depression Scale (HADS)), Health-related quality of life (Psychological General Well-Being Index (PGWB)), Women’s Health Questionnaire (WHQ), Blood lipid profile, serum hormones, growth and metabolic factors (follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, sex hormone-binding globulin, IGF–I and its binding proteins), and coagulation factors (antitrombin, factor V Leiden, factor II mutation, cardiolipin-ab, Lupus anticoagulant, Protein C activity, Protein S free, APT-time, fibrinogen, prothrombin complex, thrombocytes).

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Countries

Sweden

Outcome results

None listed