Micronized Progesterone Versus Norethisterone Acetate in Combination With Estrogen as Menopausal Hormone Therapy
Recruiting
Phase 3
Interventional Study
Menopausal Symptoms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 – 60
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 520 (estimated)
- Sponsor
- Angelica Lindén Hirschberg · Other
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About This Trial
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 br…
Trial Locations
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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…
Contacts
Angelica L Hirschberg, MD, PhD
+46 70 255 99 24
angelica.linden-hirschberg@regionstockholm.se
CONTACT