Study on the Safety of Micronized Progesterone and Norethisterone Acetate with Estradiol for Menopausal Symptoms in Women

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What is this study about?

This clinical trial is focused on studying the safety of treatments for women experiencing menopausal symptoms, such as hot flashes, sweating, and sleep problems. The study involves two main treatments: oral micronized progesterone and norethisterone acetate, both used in combination with estradiol, a form of estrogen. The purpose of the study is to compare the effects of these treatments on breast and endometrial health over a one-year period.

Participants in the study will be randomly assigned to receive either the progesterone or norethisterone acetate treatment, along with estradiol. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment is being given to each participant. This helps ensure that the results are unbiased. The study will also include a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, participants will undergo regular check-ups to monitor their health, including mammograms to assess breast density and ultrasounds to evaluate the thickness of the endometrium, which is the lining of the uterus. The study aims to provide valuable information on the safety and effects of these hormone therapies for managing menopausal symptoms.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that you are a healthy, naturally postmenopausal woman aged 45-60 years with climacteric symptoms such as sweating, hot flushes, and sleep problems.

Your body mass index (BMI) should be between 19 and 32 kg/m², and you must have an intact uterus. If you have previously used menopausal hormone therapy (MHT), a washout period of 8 weeks for oral MHT and 4 weeks for transdermal MHT or local estrogen treatment is required before screening.

2 randomization and treatment allocation

After eligibility is confirmed, you will be randomly assigned to one of two treatment groups in a double-blind manner. This means neither you nor the researchers will know which treatment you are receiving.

The treatments involve either oral micronized progesterone (mP) or norethisterone acetate (NETA), both in combination with estradiol.

3 treatment administration

You will take the assigned medication daily for one year. The medications are administered orally.

The specific medications include Utrogestan (progesterone) as a soft vaginal capsule, Estrofem (estradiol) as a film-coated tablet, and Activelle (norethisterone acetate and estradiol) as a film-coated tablet.

4 monitoring and assessments

Throughout the study, regular monitoring will occur to assess the effects of the treatment. This includes evaluating changes in mammographic breast density and endometrial safety.

Secondary assessments involve monitoring endometrial thickness, bleeding patterns, and various health-related quality of life measures. Blood tests will be conducted to analyze hormone levels and other health markers.

5 completion of study

At the end of the one-year treatment period, a final assessment will be conducted to evaluate the overall effects of the treatment on breast and endometrial safety.

The study is expected to conclude by February 28, 2025.

Who Can Join the Study?

Must be a healthy and naturally postmenopausal woman. This means you have not had a menstrual period for more than one year, or your FSH (a hormone) level is greater than 40 IE/L.
Must be experiencing climacteric symptoms, which include sweating, hot flushes, and sleep problems that negatively affect your quality of life.
Must be between the ages of 45 and 60 years old.
Must have a BMI (Body Mass Index) greater than 19 kg/m² and less than or equal to 32 kg/m². BMI is a measure of body fat based on height and weight.
Must have an intact uterus, meaning your uterus has not been removed.
If you have used MHT (Menopausal Hormone Therapy) before, you must stop using oral MHT for 8 weeks and transdermal or local estrogen treatment for 4 weeks before the screening.
Must provide written informed consent, which means you agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

Participants cannot be male. Only females are eligible for this study.
Participants must not belong to a vulnerable population, which means they should not be in a group that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Karolinska University Hospital	Solna	Sweden
Uzykxjc Uzyxtyhaco Hihvnsdx	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	01.10.2021

Trial locations

Investigated drugs:

Micronized Progesterone is a form of the hormone progesterone that is processed into tiny particles to improve its absorption when taken orally. In this study, it is used in combination with estrogen to assess its safety and effects on breast and endometrial health in women undergoing menopausal hormone therapy.

Norethisterone Acetate is a synthetic form of the hormone progesterone. It is used in this study alongside estrogen to compare its effects on breast density with those of micronized progesterone in women receiving menopausal hormone therapy.

Estradiol is a form of estrogen, a hormone that plays a crucial role in the female reproductive system. In this trial, estradiol is combined with either micronized progesterone or norethisterone acetate to evaluate the safety and effects on breast and endometrial health in women undergoing menopausal hormone therapy.

Climacteric symptoms – These symptoms occur during the transition to menopause, known as the climacteric period. They include hot flashes, night sweats, mood swings, and sleep disturbances. Women may also experience changes in menstrual cycles, such as irregular periods. The symptoms are caused by hormonal changes, particularly the decrease in estrogen levels. This period can last for several years and varies greatly among individuals. Some women may also experience joint pain, headaches, and changes in sexual function.

Trial ID:

2024-520435-33-00

Protocol code:

PROBES

NCT ID:

NCT05586724

Trial Phase:

Therapeutic confirmatory (Phase III)

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