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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)
EU CTIS ID: 2024-520435-33-00
What this study is testing
Part 1 Breast safety - a double-blind, randomized study design: To compare the effects of one year treatment with mP versus NETA, both in combination with estradiol, on mammographic breast density. Part 2 Endometrial safety – open, single arm, study design: To evaluate the effect of one-year treatment with mP in continuous combination with estradiol on endometrial pathology (hyperplasia and cancer).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Previous history or risk factors for breast cancer, breast cancer in situ or abnormal mammogram at baseline as assessed clinically by a radiology expert
- Alcohol and/or drug abuse
- Clinically significant findings on physical and/or gynecological examination at baseline
- Hypersensitivity to any of the study treatments
- Previous history or risk factors for endometrial cancer or hyperplasia or abnormal/proliferative endometrial biopsy at baseline
- Vaginal bleeding
See the full eligibility 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
- Previous history or risk factors for breast cancer, breast cancer in situ or abnormal mammogram at baseline as assessed clinically by a radiology expert
- Alcohol and/or drug abuse
- Clinically significant findings on physical and/or gynecological examination at baseline
- Hypersensitivity to any of the study treatments
- Previous history or risk factors for 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 or risk factor for cardiovascular disease including thromboembolic disorder or cerebrovascular disease
- History or presence of liver and gallbladder 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
- Porphyria, Systemic lupus erythematosus and otosclerosis
- Current use of MHT or local estrogen treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.