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)

Phase 1

• Conditions: Climacteric symptoms; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-001624-17-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 520

Inclusion Criteria

- Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH > 40 IE/L)
with climacteric symptoms (sweating, hot flush and sleep problems) that adversely affect quality of life.
- Age 45-60 years
- BMI > 19 kg/m2 and = 32 kg/m2
- Intact uterus
- In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local
estrogen treatment before screening
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 520
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous history of breast cancer or abnormal mammogram at baseline as assessed clinically by a radiology
expert
- Previous history of endometrial cancer or hyperplasia or abnormal/proliferative endometrial biopsy at
baseline
- Vaginal bleeding
- Any concomitant medical treatment except for well-controlled hypertension, non-insulin treated type 2
diabetes, asthma and hypothyroidism
- History or presence of cardiovascular disease including thromboembolic disorder or cerebrovascular disease
- History or presence of liver disease, familial hyperlipidemia, epilepsy or classical migraine with aura
- History or presence of clinically significant depression or other psychiatric disorder that might in anyway
compromise the performance of the trial or undermine its scientific validity
- Current use of MHT or local estrogen treatment
- Alcohol and/or drug abuse
- Clinically significant findings on physical and/or gynecological examination at baseline
- Hypersensitivity to any of the study treatments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified