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The effect of transdermal 17-β-estradiol/progesterone supplementation on glucose regulation in peri- and postmenopausal women with type 1 and type 2 diabetes
EU CTIS ID: 2025-523214-83-00
What this study is testing
The primary objective is to determine the effect of transdermal 17-β-estradiol combined with oral micronized progesterone on glucose regulation in peri- and early postmenopausal women with diabetes mellitus (type 1 or 2) and climacteric symptoms.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Late perimenopausal, defined as changes in the menstrual cycle with an interval of amenorrhea of >= 60 days (STRAW+10 stage –1) OR early postmenopausal (STRAW+10 stage +1), defined as final menstrual cycle more than 1 years prior to inclusion.
- Final menstrual cycle < 5 years prior to inclusion
- One or more menopause-associated symptoms. For example: vasomotor symptoms (hot flushes and sweats), musculoskeletal symptoms (joint and muscle pain), effects on mood (low mood), sexual difficulties (low sexual desire)
- Additionally, for T1DM: Diabetes Mellitus type 1 diagnosed before menopause, and at least 6 months prior to the study
- Additionally, for T2DM: Diabetes Mellitus type 2 diagnosed before menopause, and at least 6 months prior to the study
- Additionally, for T2DM: Use of insulin, at least 1 time daily
You likely can't join if
- Contra-indication for transdermal estrogen and/or progesterone therapy: Presence or sus-picion or history of breast cancer, endometrial cancer, ovarian cancer, presence or history of venous thromboembolism (unless the individual is using anticoagulation therapy), active arterial thrombosis or in the past 6 months (e.g. myocardial infarction, angina pectoris) in-herited or acquired thrombophilia, acute liver disease, or a history of liver disease as long as liver function values have not normalized, untreated endometrial hyperplasia, abnormal vaginal bleeding, porphyria, uncontrolled or severe hypertension.
- Chronic kidney disease defined as eGFR < 30 mL/min/1.73m2
- Additionally, for T1DM: Use of glucose-regulating medications other than insulin, such as metformin, GLP-1/GIP re-ceptor agonists, sulfonylureas, SGLT2 inhibitors, and DPP4 inhibitors
- Additionally, for T2DM: Changes to glucose-regulating medications (metformin, GLIP-1/GIP receptor agonists, sulfonylureas, SGLT2 inhibitors, DPP4 inhibitors) other than insulin, including starting, stopping or altering the dosage, in three months prior to the study period. (Note that these medications may be used, provided they are not changed three months prior to the study.)
- Participants with BRCA1 or 2 gene or PTEN mutation
- Participants with a first degree relative with (a history of) breast cancer
See the full eligibility criteria
Who can join
- Late perimenopausal, defined as changes in the menstrual cycle with an interval of amenorrhea of >= 60 days (STRAW+10 stage –1) OR early postmenopausal (STRAW+10 stage +1), defined as final menstrual cycle more than 1 years prior to inclusion.
- Final menstrual cycle < 5 years prior to inclusion
- One or more menopause-associated symptoms. For example: vasomotor symptoms (hot flushes and sweats), musculoskeletal symptoms (joint and muscle pain), effects on mood (low mood), sexual difficulties (low sexual desire)
- Additionally, for T1DM: Diabetes Mellitus type 1 diagnosed before menopause, and at least 6 months prior to the study
- Additionally, for T2DM: Diabetes Mellitus type 2 diagnosed before menopause, and at least 6 months prior to the study
- Additionally, for T2DM: Use of insulin, at least 1 time daily
What rules you out
- Contra-indication for transdermal estrogen and/or progesterone therapy: Presence or sus-picion or history of breast cancer, endometrial cancer, ovarian cancer, presence or history of venous thromboembolism (unless the individual is using anticoagulation therapy), active arterial thrombosis or in the past 6 months (e.g. myocardial infarction, angina pectoris) in-herited or acquired thrombophilia, acute liver disease, or a history of liver disease as long as liver function values have not normalized, untreated endometrial hyperplasia, abnormal vaginal bleeding, porphyria, uncontrolled or severe hypertension.
- Chronic kidney disease defined as eGFR < 30 mL/min/1.73m2
- Additionally, for T1DM: Use of glucose-regulating medications other than insulin, such as metformin, GLP-1/GIP re-ceptor agonists, sulfonylureas, SGLT2 inhibitors, and DPP4 inhibitors
- Additionally, for T2DM: Changes to glucose-regulating medications (metformin, GLIP-1/GIP receptor agonists, sulfonylureas, SGLT2 inhibitors, DPP4 inhibitors) other than insulin, including starting, stopping or altering the dosage, in three months prior to the study period. (Note that these medications may be used, provided they are not changed three months prior to the study.)
- Participants with BRCA1 or 2 gene or PTEN mutation
- Participants with a first degree relative with (a history of) breast cancer
- Known hypersensitivity to the excipients in the estradiol patch: acrylate copolymer, poly-ethylene terephthalate, α-tocopherol, or progesterone capsule: soy allergy or peanut aller-gy
- Hysterectomy
- Premature menopause (menopause age < 40 years)
- Hormonal contraception or hormone replacement therapy use (estradiol with or without progesterone) within three months before inclusion
- Use of systemic glucocorticosteroids less than 1 month prior to the study or anticipated need for systemic steroids during the study period (e.g., for Crohn’s disease or astma/COPD). Incidental use of topical agents is allowed.
- Active malignancy or history of treated cancer within 24 months of enrollment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.