A study of estradiol and progesterone treatment for blood sugar control in women with type 1 or type 2 diabetes during or after menopause

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What is this study about?

This study involves women going through or after menopause who also have diabetes mellitus, which can be either type 1 diabetes or type 2 diabetes. Diabetes is a condition where the body has trouble controlling blood sugar levels. Menopause is the time in a woman’s life when her monthly periods stop, and this can cause various symptoms such as hot flushes, sweating, joint pain, low mood, and changes in sexual desire. The study will use two medications: estradiol, which is given through patches placed on the skin, and progesterone, which is taken as capsules by mouth. These are hormones that naturally decrease during menopause.

The purpose of this study is to find out how these hormone medications affect blood sugar control in women with diabetes who are experiencing menopause symptoms. The study will look at whether using estradiol patches combined with progesterone capsules helps to keep blood sugar levels within a healthy range. During the study, participants will have periods where they receive the hormone treatment and periods where they do not receive treatment. Blood sugar levels will be measured continuously using a monitoring device worn on the body for two weeks at different times during the study.

The study will also look at other health measures, including how well insulin works in the body, changes in blood pressure, cholesterol levels, liver fat content, muscle strength, and various symptoms related to menopause and diabetes. Participants will complete questionnaires about their symptoms, sleep quality, mood, and overall quality of life. Some participants will undergo additional tests such as an MRI scan to measure liver fat and specialized tests to measure how the body responds to insulin. The entire treatment period will last up to 60 months, during which participants will be monitored to see how the hormone treatment affects their diabetes control and overall health.

1 Initial treatment period without hormone supplementation

During the first 12 weeks, no hormone treatment will be provided. This period serves as a comparison phase.

A continuous glucose monitor (a small sensor that tracks blood sugar levels throughout the day and night) will be worn during the final 2 weeks of this period to measure glucose levels.

Blood samples will be taken to measure HbA1c (a marker showing average blood sugar levels over the past 2-3 months).

Daily insulin dose and carbohydrate-insulin ratio (the amount of insulin needed to process carbohydrates) will be recorded.

Blood pressure will be monitored over a 24-hour period using a portable device.

A lipid profile (cholesterol and fat levels in the blood) will be assessed through blood tests.

Liver fat content will be measured using a fibroscan (a non-invasive scan that assesses liver health). For those with type 2 diabetes, an additional MRI-PDFF scan (a detailed imaging technique) may be performed to measure total liver fat.

Handgrip strength will be tested using a device called a dynamometer to assess muscle function.

Insulin sensitivity (how effectively the body responds to insulin) will be measured through a procedure called a hyperinsulinemic-euglycemic clamp, which involves controlled insulin and glucose infusions.

Several questionnaires will be completed to assess menopause symptoms, sleep quality, mood, diabetes-related concerns, and overall quality of life.

2 Hormone supplementation treatment period

For the next 12 weeks, hormone supplementation will be administered.

Estradiol will be provided through a transdermal patch (a patch applied to the skin) delivering 50 micrograms per 24 hours. The patch is applied to the skin and replaced according to the product instructions.

Micronised progesterone will be taken orally (by mouth) in the form of soft capsules. The specific dosage and frequency will be determined based on individual needs.

During the final 2 weeks of this treatment period, a continuous glucose monitor will be worn again to track blood sugar levels.

The same assessments performed during the first period will be repeated, including blood tests for HbA1c and lipid profile, 24-hour blood pressure monitoring, liver scans, handgrip strength testing, and the insulin sensitivity procedure.

Daily insulin dose and carbohydrate-insulin ratio will continue to be recorded.

The same questionnaires regarding menopause symptoms, sleep quality, mood, diabetes-related concerns, and quality of life will be completed again.

3 Final comparison and assessment

The glucose data collected during the final 2 weeks of the hormone treatment period will be compared with the data from the final 2 weeks of the initial period without treatment.

The primary focus will be on time-in-range, which measures the percentage of time blood sugar levels remain within the target range.

Additional glucose measurements will include time-below-range (percentage of time blood sugar is too low), time-above-range (percentage of time blood sugar is too high), and glucose variability (how much blood sugar levels fluctuate).

Changes in all other measured parameters, including insulin requirements, cardiovascular risk factors, liver fat, muscle strength, and quality of life indicators, will be evaluated.

Who Can Join the Study?

You must be in late perimenopause, which means your menstrual periods have changed and you have not had a period for at least 60 days, or you must be in early postmenopause, which means your final menstrual period was more than 1 year ago.
Your final menstrual period must have occurred less than 5 years before joining the study.
You must have one or more symptoms related to menopause, which is the time when menstrual periods stop. These symptoms may include hot flushes and sweating, joint and muscle pain, low mood, or low sexual desire.
If you have Type 1 Diabetes Mellitus, which is a condition where your body does not produce insulin to control blood sugar, you must have been diagnosed with this before menopause and at least 6 months before the study.
If you have Type 2 Diabetes Mellitus, which is a condition where your body does not use insulin properly to control blood sugar, you must have been diagnosed with this before menopause and at least 6 months before the study.
If you have Type 2 Diabetes Mellitus, you must be using insulin, which is a medicine that helps control blood sugar, at least once daily.
You must be female.
You must be an adult between 18 and 64 years of age.

Who Cannot Join the Study?

You cannot participate if you are male, as this study is only for women
You cannot participate if you are not in perimenopause (the time before your periods stop completely) or early postmenopause (the time shortly after your periods have stopped)
You cannot participate if you do not have diabetes mellitus (a condition where your blood sugar levels are too high), either type 1 (where your body does not make insulin) or type 2 (where your body does not use insulin properly)
You cannot participate if you do not have climacteric symptoms (uncomfortable symptoms related to menopause, such as hot flashes, night sweats, or mood changes)
You cannot participate if you are outside the adult age range required for this study

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Aidjasmtg Ulx	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2025

Trial locations

Investigated drugs:

17-β-estradiol is a hormone therapy that is applied through the skin using a patch. Estradiol is a form of estrogen, which is a female hormone that decreases during menopause. This medication is being tested to see if it can help improve blood sugar control in women going through menopause who have diabetes.

Progesterone is a hormone therapy that is taken by mouth as a capsule. Progesterone is another female hormone that works together with estrogen in the body. In this study, it is being used along with estradiol to see if the combination can help manage blood sugar levels in menopausal women with diabetes.

Investigated diseases:

Diabetes Mellitus – Diabetes mellitus is a chronic condition that affects how the body processes blood sugar, also known as glucose. In this disease, the body either does not produce enough insulin or cannot effectively use the insulin it produces. Insulin is a hormone that helps glucose enter cells to be used for energy. When glucose cannot enter cells properly, it builds up in the bloodstream, leading to high blood sugar levels. There are two main types: type 1, where the body produces little or no insulin, and type 2, where the body does not respond well to insulin. Over time, persistently high blood sugar levels can affect various organs and systems in the body.

Perimenopause – Perimenopause is the natural transition period leading up to menopause when a woman’s body gradually produces less estrogen. This phase typically begins several years before menopause, often in a woman’s 40s, but can start earlier. During this time, the ovaries slowly decrease their production of reproductive hormones, causing irregular menstrual cycles. Women may experience various symptoms including hot flashes, night sweats, sleep disturbances, and mood changes. The length of perimenopause varies among women, lasting anywhere from a few months to several years. This transition ends when a woman has gone 12 consecutive months without a menstrual period, marking the beginning of menopause.

Menopause – Menopause is the point in time when a woman permanently stops having menstrual periods, marking the end of reproductive years. It is officially diagnosed after 12 consecutive months without menstruation, typically occurring between ages 45 and 55. Menopause happens because the ovaries stop releasing eggs and producing most of their estrogen and progesterone. The decrease in these hormones can cause symptoms such as hot flashes, vaginal dryness, mood changes, and sleep problems. Some women experience mild symptoms while others have more significant effects on their daily life. The hormonal changes associated with menopause are permanent and represent a natural biological process.

Trial ID:

2025-523214-83-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study of estradiol and progesterone treatment for blood sugar control in women with type 1 or type 2 diabetes during or after menopause

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