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Bioequivalence of Testosterone Transdermal Gel in Healthy Female Subjects
EU CTIS ID: 2022-501514-56-00
What this study is testing
To compare the bioavailability between Test and Reference products.
- Human Pharmacology (Phase I)- Bioequivalence Study
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
- Free written informed consent prior to any procedure required by the study.
- Non-smoker or ex-smoker (i.e. someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
- Willingness to accept and comply with all study procedures and restrictions.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate.
- Female subject between 45 and 65 years, inclusive, at the time of signing the informed consent.
- Post-menopausal, defined as amenorrhea for at least 12 months without an alternative medical cause, or history of hysterectomy and bilateral oophorectomy at least 6 months prior to Screening.
You likely can't join if
- Known hypersensitivity/allergy reaction to any of the ingredients of the study products.
- History of significant dermatological problems (e.g., severe or cystic acne) or concomitant skin disease within the last 5 years, or a history of drug-induced contact dermatitis.
- Use of hormonal replacement therapy within the previous 6 months.
- Blood hemoglobin below the lower limit of the normal range.
- Blood ferritin below the lower limit of the normal range.
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
See the full eligibility criteria
Who can join
- Free written informed consent prior to any procedure required by the study.
- Non-smoker or ex-smoker (i.e. someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
- Willingness to accept and comply with all study procedures and restrictions.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate.
- Female subject between 45 and 65 years, inclusive, at the time of signing the informed consent.
- Post-menopausal, defined as amenorrhea for at least 12 months without an alternative medical cause, or history of hysterectomy and bilateral oophorectomy at least 6 months prior to Screening.
- Blood follicle stimulating hormone (FSH) compatible with post-menopausal state (23 - 116.3 IU/L).
- Body mass index (BMI) of 18.5 to 30.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination (including detailed skin examination and vital signs).
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
What rules you out
- Known hypersensitivity/allergy reaction to any of the ingredients of the study products.
- History of significant dermatological problems (e.g., severe or cystic acne) or concomitant skin disease within the last 5 years, or a history of drug-induced contact dermatitis.
- Use of hormonal replacement therapy within the previous 6 months.
- Blood hemoglobin below the lower limit of the normal range.
- Blood ferritin below the lower limit of the normal range.
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
- Estimated renal creatinine clearance (CrCL) below the lower limit of normal range (80-110 mL/min), based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2.
- Positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibodies (anti-HCV) or anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab).
- SBP >150 mmHg and/or DBP >90 mmHg, measured on the dominant arm, after at least 3 minutes in seated position.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug within the previous 6 months.
- Known severe hypersensitivity reaction to any other drug.
- Average weekly alcohol consumption of >7 units within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g. coffee, tea, cola, sodas, chocolate) equivalent to >500 mg methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, lowfat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- Is pregnant or breast-feeding.
- Presence of a skin condition or scar tissue that could interfere with absorption, skin irritation/tolerability assessments, or assessment of any reaction to study drugs.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
- Any general condition or local condition (e.g. skin disorder) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Use of any method of hair removal (e.g. waxing, shaving, epilating, laser, tweezers) at the application site within the previous 5 days.
- Sunbathing or using tanning beds at the application site within the previous 2 days.
- Use of topical products containing medication (including creams, oils, lotions, ointments, gels, topical solutions or patches) at the application site within the previous 14 days.
- Use of topical products not containing medication (including make-up, sunscreen, creams, oils, lotions, powders, alcohol) at the gel application site within the previous 2 days.
- Use of saunas or swimming within 2 days prior to admission.
- Use of prescription or non-prescription medicinal products (such as vitamins, food supplements and herbal supplements, including St John’s Wort) within the previous 14 days, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Consumption of Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous 7 days.
- Positive result in drugs-of-abuse or ethanol tests.
- Any other condition that the investigator considers to render the subject unsuitable for the study period.
- Known or suspected carcinoma of the breast.
- Abnormal genital bleeding.
- Thrombophilia or thromboembolic disorder.
- History of heart failure.
- History of diabetes.
- Migraine or epilepsy.
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, 65+ 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.