Menopause

Menopausal hormone therapy is an effective treatment for severe menopausal symptoms, affecting more than 70% of women and impacting quality of life, sleep, mood, work capacity, and overall wellbeing. Despite its effectiveness, MHT remains underused in Sweden, only 5–6% of women receive treatment today, largely due to misconceptions, outdated fears about risks, and limited access to clinicians with updated knowledge.

This large-scale, multidisciplinary project aims to fill major knowledge gaps and provide modern, individualized, and evidence-based guidance on MHT for women and healthcare providers. The project combines:

• Two national surveys exploring attitudes, preferences, and experiences of women and clinicians.
• Large national register studies of over 1 million women, examining associations between different MHT regimens and outcomes such as cancer, cardiovascular disease, and mental health.
• A multicenter double-blind randomized controlled trial comparing micronized progesterone vs. norethisterone acetate in combination with estradiol.

The goal is to support women in making informed choices, provide clinicians with clearer guidance, and contribute to updated national guidelines for safe and individualized menopausal hormone therapy.

Funding

Swedish Research Council (Vetenskapsrådet)

Ansvarig forskare/kontaktperson

Menopausal hormone therapy (MHT) is prescribed for menopausal symptoms, a very common condition during a woman's menopause. During the 90s, the use of MHT was widespread and was then also used as a preventive treatment for cardiovascular diseases and to provide increased well-being. Around the turn of the millennium, however, studies appeared that indicated an increased incidence of cardiovascular disease, breast cancer and stroke among those treated. Despite limitations in these studies and the advent of newer data that could not confirm these risks, a reduced prescription of MHT and a reduced demand among women, even among those with pronounced menopausal symptoms, is still noted in Sweden. To avoid unnecessary suffering, it is important to increase the level of evidence in this area. The project aims to:

1. Investigate current attitude towards and experience of MHT from the perspective of both the woman and the prescriber through two survey studies aimed at perimenopausal women and gynecologists and general practitioners respectively.
2. Map actual MHT use among women in Sweden with a focus on changes over time and possible differences in prescribing depending on socio-economic status and region through data from several national registers and examine differences in the occurrence of several health outcomes between women exposed to MHT and healthy controls.

Funding

Region Uppsala, ALF, Cancerfonden, Makarna Erikssons fond

Ansvarig forskare/kontaktperson

Prof. Alkistis Skalkidou
Email: alkistis.skalkidou@uu.se

Learn more at MERITs webpage

This is a study with the aim of investigating Swedish women's experience of and perception of menopausal symptoms and their treatment.

Participate in the study

What does menopause and menopausal hormone therapy mean?

Menopause, also called menopause, refers to the time before and after the last menstruation. When menopause begins varies from woman to woman and depends on many different factors. Symptoms related to the menopause vary between different women, partly which symptoms you get and how pronounced they are, partly how long you have symptoms. In general, it can be said that menopause can last up to 10 years and extends from the first sign of reduced hormone production to the time after the last menstruation. Menopause is a very common condition during a woman's menopause, up to seven out of ten women are affected and a third of these women need an effective and safe treatment to achieve a good quality of life. Menopausal hormone therapy (abbreviated MHT) involves drugs containing hormones that are prescribed by doctors to treat menopausal symptoms.

Why is the study done?

The main purpose of the study is to investigate Swedish women's experience of and perception of menopausal symptoms and its treatment with particular focus on perceived risks and benefits of the treatment. The study will also shed light on the women's perception of the availability of care as well as the possibility of individually tailored counseling and treatment of menopausal symptoms, including treatment with new progestogens.The goal of the study is to provide increased knowledge in this area and that the study results will in the long run be the basis for possible changes in healthcare which provide the opportunity for better and more modern counseling and treatment of women with menopausal symptoms.

How does the study work?

Women aged 45–60 are welcome to participate in the study. Participation in the study is based solely on age, own experience of hormonal treatment of menopausal symptoms is not necessary. Participants in the study must answer a web-based survey that takes approximately 15 minutes to complete. Participation is completely voluntary and anonymous.

If you are interested in participating in the study and/or would like more information, follow the link below:
https://redcap.link/klimakterie

Responsible for the project

Rebecca Götze Eriksson, doktorand, bitr. överläkare, rebecca.gotze_eriksson@kbh.uu.se

Stavros Iliadis, docent, överläkare, stavros.iliadis@kbh.uu.se

Approximately one in three menopausal women suffers badly from sweating, hot flushes and sleep problems and therefore desires some form of treatment. Estrogen medication provides very good symptom relief and can be recommended to most women who have menopausal symptoms with reduced quality of life. To avoid unwanted stimulation of the uterine lining, estrogen is usually combined with progesterone (corpus luteum hormone) in synthetic form, so-called the progestin. Only women who have had their uterus removed can be treated with estrogen alone.

FFor women who start hormone medication close to menopause (last menstruation), the treatment has many positive health effects, including reducing the risk of bone calcification and cardiovascular disease and extending life. However, long-term hormone treatment gives a slightly increased risk of breast cancer. Today we know that the risk of breast cancer mainly applies to combination treatment with estrogen and progestin, while estrogen without progestin increases the risk very little or not at all.

Many women are hesitant to start hormone therapy for fear of breast cancer. The consequence may instead be that women suffer in silence, try less proven alternatives or switch to antidepressant medication. There is therefore a great need to find safe hormonal treatment in the menopause that protects the endometrium but at the same time does not increase the risk of breast cancer.

In Sweden, standard treatment is estrogen together with progestin (norethisterone acetate, NETA), while in other European countries natural, so-called micronized progesterone (mP) is used instead. Research results speak for a lower risk of breast cancer when using estrogen combined with natural progesterone instead of progestin, while the safety for the endometrium may possibly be lower. In Sweden, there is no natural progesterone as a registered product for hormonal treatment in the menopause, but it can be prescribed under licence. In recent years, the licensed prescription of progesterone has increased dramatically.

Why is the study done?

In order to meet women's needs and wishes for hormone treatment, it is important to gain increased knowledge about how natural progesterone in combination with estrogen affects the breast and endometrium compared to standard treatment. The purpose of the study is to explore the balance between benefits and risks of hormone therapy with NETA compared with micronized progesterone, in combination with estrogen. The study is expected to provide increased knowledge about both breast and uterine safety with estrogen treatment in combination with natural progesterone compared to progestogen

How does the study work?

Participants are randomly assigned to one of two treatment options, and neither the woman nor the study staff know which treatment they will receive. The treatment lasts for 12 months and study participants are followed up with regular visits to a nurse and gynecologist. The study includes a gynecological examination, control with blood samples, sampling of the endometrium and examination of the breasts with mammography.

Inclusion criteria are that you must be between 45–60 years old, have a BMI between 19–32 and have the uterus still but have stopped menstruating.

The study is conducted at Karolinska Institutet and Uppsala University.

Responsible for the project at Uppsala University

Stavros Iliadis, docent, överläkare, stavros.iliadis@kbh.uu.se
Alkistis Skalkidou, professor, överläkare, alkistis.skalkidou@kbh.uu.se

Are you interested in participating?

Read more and register here: https://www.accindi.se/studies/969_kombinerad-hormonbehandling-med-naturligt-progesteron-jmfrt-med-syntetiskt-progesteron-hos-kvinnor-i-klimakteriet

Alternatively, you can contact research nurse Alexandra Rudenscholtz at the clinical research clinic, Akademiska sjukhuset, Uppsala,alexandra.a.rudenscholtz@akademiska.se