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New treatment option for Energy Balance
Official title The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance
ClinicalTrials.gov ID: NCT07620587
What this study is testing
What is Estradiol Only?
Estradiol Only is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for energy balance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to determine if estradiol and progesterone are involved in appetite regulation and energy balance. The study aims to complete a 13 day randomized controlled trial (RCT) where oral supplementation of estradiol only, progesterone only, a combination of each, or a placebo in young males will be provided.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 30, men only. Healthy volunteers may be eligible.
You may be able to join if
- ages 18-30 years
- deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
- non-smoking
You likely can't join if
- failure to meet inclusion criteria
- contraindications to exercise as indicated by the (CSEP-GAQ)
- hypersensitivity or allergy to estradiol, progesterone, cellulose, or capsule components
- having been diagnosed with any metabolic disease (ie. diabetes, metabolic syndrome) or current diagnosis of overweight/obesity (BMI \> 30.0)
- personal of family history of stroke or thrombotic (blood clot) disease, blood clot disorder, venous or arterial thromboembolic disease, or any...
- currently taking anticoagulants, antidiabetic medications, cyclosporine, antihypertensives, and CYP3A4 inducers or inhibitors (e.g., rifampin...
See the full eligibility criteria
- ages 18-30 years
- deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
- non-smoking
- failure to meet inclusion criteria
- contraindications to exercise as indicated by the (CSEP-GAQ)
- hypersensitivity or allergy to estradiol, progesterone, cellulose, or capsule components
- having been diagnosed with any metabolic disease (ie. diabetes, metabolic syndrome) or current diagnosis of overweight/obesity (BMI \> 30.0)
- personal of family history of stroke or thrombotic (blood clot) disease, blood clot disorder, venous or arterial thromboembolic disease, or any possible blood clotting disease
- currently taking anticoagulants, antidiabetic medications, cyclosporine, antihypertensives, and CYP3A4 inducers or inhibitors (e.g., rifampin, ketoconazole, St. John's Wort)
- known liver dysfunction or liver disease
- history of ophthalmic vascular disease
- hormone-dependent malignancies or previous diagnosis of cancer
- recent major surgery (within \~6 months)
- prolonged use of a cast or presence of immobility deeming inability to exercise, diagnosis of inflammatory disorders (ie. rheumatoid arthritis, celiac disease, inflammatory bowel disease)
- history of sensitivity to or extreme nausea/vomiting or any gastrointestinal disorder
- diagnosis of mental health or mood disorder
- presence of abnormal eating behaviours as assessed by the Food Cravings State Questionnaire and the Three Factor Eating Questionnaire
- diagnosed or presence of porphyria or classical migraines
The study team makes the final eligibility decision.
Where it's taking place
- Waterloo, Ontario, Canada
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 male, 18 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waterloo, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.