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โ† Trials
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Micronized Progesterone Versus Norethisterone Acetate in Combination With Estrogen as Menopausal Hormone Therapy

RecruitingPhase 3Ages 45 Years - 60 YearsFemaleAngelica Lindรฉn Hirschberg
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In plain words

What the trial is, and whether it could suit you

About one third of all women during menopausal transition have significant climacteric symptoms with considerable impact on quality of life. Meta-analysis has shown a beneficial risk profile with menopausal hormone therapy (MHT) for women 50 to 60 years. Still, there is a great need to find safe MHT able to control excessive endometrial stimulation by estrogen without stimulatory effects on the breast by the combination of estrogen/progestogen. Recent observational studies indicate a lower risk for breast cancer using micronized progesterone (mP) combined with estrogen but increased risk of endometrial cancer than by standard MHT. In a randomized trial, the balance between benefits and risks of mP vs. progestogens (norethisterone (NETA)) in combination with estrogen will be explored. For apparent reasons, long-term largescale clinical trials with endometrial and breast cancer as the prim

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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
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What it tests

  • Micronized progesterone in continuous combination with oral estrogen
  • Norethisterone acetate in continuous combination with oral estrogen
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Where

1 site
Karolinska University Hospital
Stockholm, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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