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A study to compare the absorption of testosterone transdermal gel in healthy female subjects

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What is this study about?

This study focuses on Male hypogonadism, a condition where the body does not produce enough of a specific hormone. The research aims to compare how much of a medication enters the bloodstream when using two different types of testosterone. The medications being compared include a transdermal gel, which is a substance applied to the skin to be absorbed into the body, and Testogel Dosiergel 16.2 mg/g gel.

Participants will receive different versions of the medication in a specific sequence to allow for a direct comparison. During the study, measurements will be taken to track the levels of the hormone in the body and to monitor safety. This includes checking physical health, skin condition, and vital signs, as well as performing an ECG, which is a test that records the electrical activity of the heart. The process involves using the gels under fasting conditions, meaning no food is consumed for a period before the medication is applied.

Who Can Join the Study?

  • You must provide your free written informed consent, which means you sign a document agreeing to participate after understanding all the details of the study.
  • You must be a non-smoker or an ex-smoker, meaning you have not used tobacco or nicotine products for at least 3 months before the start of the study.
  • You must be willing to follow all the rules and steps required by the study.
  • You must have a negative SARS-CoV-2 test (a test showing you do not have COVID-19) or a valid EU Digital COVID-19 Recovery Certificate.
  • You must be a female between the ages of 45 and 65 years.
  • You must be post-menopausal, which means you have gone through the stage of life where periods have stopped for at least 12 months without another medical reason, or you have had surgery to remove the uterus (hysterectomy) and both ovaries (bilateral oophorectomy) at least 6 months ago.
  • Your blood levels of follicle stimulating hormone (FSH), which is a hormone that helps regulate the reproductive system, must be within a specific range (23 to 116.3 IU/L) that confirms you are in menopause.
  • Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must be between 18.5 and 30.0.
  • You must have no significant medical history of diseases that could affect the study.
  • A physical examination, including a check of your skin and vital signs (such as blood pressure and heart rate), must show no significant health problems.
  • An ECG, which is a test that records the electrical activity of your heart, must show no significant abnormalities.
  • Your clinical laboratory tests, such as blood or urine tests, must show no significant abnormalities.

Who Cannot Join the Study?

  • You have a known allergy or hypersensitivity (an extreme immune reaction) to any of the ingredients used in the study products.
  • You have had serious skin problems, such as severe or cystic acne, any skin disease in the last 5 years, or contact dermatitis (an itchy skin rash caused by touching something) caused by medication.
  • You have used hormone replacement therapy (medicine used to balance hormones) within the last 6 months.
  • Your hemoglobin levels (a protein in red blood cells that carries oxygen) are too low.
  • Your ferritin levels (a protein that stores iron in your body) are too low.
  • Your levels of ALT or AST (enzymes that indicate liver health) are higher than the normal range.
  • Your creatinine clearance (a measure of how well your kidneys filter waste from your blood) is lower than the normal range.
  • You tested positive for Hepatitis B, Hepatitis C, or HIV (viruses that affect the immune system or liver).
  • Your blood pressure is high, specifically a systolic (top number) pressure over 150 mmHg or a diastolic (bottom number) pressure over 90 mmHg.
  • You tested positive for illegal drugs or alcohol.
  • You have received a depot injection (a long-acting medication injected into muscle) or an implant within the last 6 months.
  • You have a known severe allergy to any other medication.
  • You consume more than 7 units of alcohol per week on average over the last 6 months.
  • You consume more than 500 mg of methylxanthines (substances found in caffeine, such as in coffee, tea, or chocolate) daily.
  • You participated in a clinical trial within the last 2 months.
  • You have participated in more than 2 clinical trials within the last 12 months.
  • You have donated blood, lost a significant amount of blood, or had plasmapheresis (a process that separates plasma from blood cells) within the last 2 months.
  • You have difficulty fasting (not eating for a period of time) or follow a special diet, such as vegan, low-fat, or low-sodium diets, that might interfere with the study meals.
  • Your veins are not suitable for intravenous puncture (inserting a needle into a vein) in either arm.
  • You are pregnant or breastfeeding.
  • You have skin conditions or scar tissue that could interfere with how the medicine is absorbed or how the skin reacts.
  • Any condition that the doctor believes makes you unsuitable for the study.
  • Any condition that could affect pharmacokinetics (how the body absorbs, moves, breaks down, and removes the medicine).
  • Any recent illness or treatment that could make participation risky or interfere with how the body processes the study drug.
  • You used hair removal methods like waxing, shaving, or lasers at the application site within the last 5 days.
  • You used sunbathing or tanning beds at the application site within the last 2 days.
  • You used any medicated creams, lotions, or patches at the application site within the last 14 days.
  • You used non-medicated products like makeup, sunscreen, or oils at the application site within the last 2 days.
  • You used a sauna or went swimming within 2 days before being admitted.
  • You used any prescription or over-the-counter medicines, including vitamins or herbal supplements, within the last 14 days, unless the doctor says it is safe.
  • You have eaten Seville oranges, pomelo, pomegranate, starfruit, or grapefruit within the last 7 days.
  • You have a known or suspected carcinoma of the breast (breast cancer).
  • You experience abnormal genital bleeding.
  • You have thrombophilia (an increased tendency to form blood clots) or a thromboembolic disorder (a condition where blood clots block a blood vessel).
  • You have a history of heart failure.
  • You have a history of diabetes.
  • You suffer from migraine (severe headaches) or epilepsy (a neurological disorder causing seizures).

Where you can join this trial?

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Other Sites

Site Name City Country Status
Bfldoezbvyca Icsirvrfzbau E Ddvaseqxvdqecnz Ez Sdnys Lndm Porto Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Not recruiting
04.01.2023

Trial locations

Investigated drugs:

Testosterone is a hormone gel applied to the skin. In this study, this gel is being tested to see how much of the medication is absorbed into the body when applied through the skin.

Testogel is a hormone gel applied to the skin. It is being used in this study as a comparison product to evaluate the effectiveness and absorption of the test gel.

Investigated diseases:

Male hypogonadism – This condition occurs when the male body does not produce enough testosterone. It is often caused by issues with the testicles or the pituitary gland. The condition can develop gradually over time. It may manifest through various physical and emotional changes. The progression depends on the underlying cause of the hormone deficiency.

Trial ID:
2022-501514-56-00
Protocol code:
BLCL-TES-EU-01
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

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