UnknownPhase 2

Product Transference Study of Testagen™ TDS®-Testosterone

96 participantsStarted 2016-11

Plain-language summary

This study will assess the potential of Testagen® TDS-Testosterone to enable transfer of Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has been applied and the potential of product to raise serum androgen levels in those women.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Healthy Volunteers
✓. Subject Couples, between 18 and 80 years of age, inclusive.
✓. The subject couple is willing and able to read, understand the Subject Information Sheets and provide written informed consent.
✓. The subject has a body mass index (BMI) within 18-30 kg/m2.
✓. The subject is in otherwise good health as determined by medical history and physical examination.
✓. Female subjects must be practicing an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives. If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained on each Treatment Day.
✓. The subject is a non-smoker.
✓. The female subject must agree to comply with the placement of an indwelling catheter on two separate occasions and the drawing of blood samples for the pharmacokinetic assessments.

Exclusion criteria

✕. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator, particularly an elevated PSA reading or positive pregnancy test.
✕. The subject has had a clinically significant illness within 30 days preceding entry into this study.
✕. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
✕. The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.
✕. The subject has used any prescription medication within 14 days or over-the-counter (OTC) medication or alcohol within 48 hours of dosing or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of study medication (excluding oral contraceptives).
✕. The subject has donated or lost a significant volume of blood (\>450mL) within four (4) weeks of the study, and their haemoglobin concentration and haematocrit have not returned to within 5% of normal.
✕. The subject has a history of substance abuse or a current positive urine drug screen.
✕. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males, and 14 for females).

What they're measuring

Transference of Topical Testosterone from Dosed Males to Female Partners As Measured by net change from Baseline of Serum Testosterone in nG/dL expressed as Maximum Serum Concentration or Cmax.

Timeframe: 30 minutes to 24 hours post dose

Trial details

NCT IDNCT02733133

SponsorTransdermal Delivery Solutions Corp

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10

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