Micronized Progesterone Versus Norethisterone Acetate in Combination With Estrogen as Menopausal Hormone Therapy

Launched by ANGELICA LINDÉN HIRSCHBERG · Oct 15, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatments for women experiencing menopausal symptoms, such as hot flashes and sleep problems. The study will compare micronized progesterone (mP) with norethisterone acetate (NETA), both combined with estrogen, to see which treatment has a better effect on breast health and the uterus over one year. Researchers want to find out if using mP can lower the risk of breast cancer while still managing menopausal symptoms effectively.

To participate in this trial, women aged 45 to 60 who are naturally postmenopausal and experiencing bothersome symptoms may be eligible, provided they have an intact uterus and a body mass index (BMI) between 19 and 32. Participants will need to stop any previous hormone treatments for a short period before starting the study. Throughout the trial, women will receive regular monitoring to ensure their safety and to check for any changes in breast and uterine health. This study aims to provide important information about safe hormone therapy options for menopausal women.

Gender

FEMALE

Eligibility criteria

• 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/or sleep problems) that adversely affect the 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
• Exclusion Criteria:
• • Previous history or risk factors for breast cancer, breast cancer in situ or abnormal mammogram at baseline as assessed clinically by a radiology expert
• • 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
• • Alcohol and/or drug abuse
• • Clinically significant findings on physical and/or gynecological examination at baseline
• • Hypersensitivity to any of the study treatments