ISRCTN13049111CompletedPhase 1
Bioavailability study of a new testosterone orodispersible tablet (ODT) administered as single doses of 6 and 12 mg to healthy postmenopausal women. Single dose, open, randomised, 3-period, 3-way cross-over exploratory bioavailability study
IBSA Institut Biochimique S.A.0 sites16 target enrollmentStarted: October 16, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Women aged between 45 and 65 inclusive
- •2. Post-menopausal status for at least 1 year
- •3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
- •4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm
- •5. Endogenous testosterone levels < 3.5 nmol/L (about 1.00 ng/mL)
- •6. Normal or not clinically relevant abnormal cervical smears at PAP test
- •7. Normal or not clinically relevant abnormal mammograms
- •8. Ability to provide informed consent
Exclusion Criteria
- •1. ECG 12-leads (supine position): clinically relevant abnormalities
- •2. Clinically relevant abnormal physical findings
- •3. Clinically relevant abnormal laboratory values
- •4. Ascertained or presumptive hypersensitivity to the active principle (testosterone) and/or formulations' ingredients
- •5. Relevant history of cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, immunological, dermatological, endocrine, genito-urinary, neurological or psychiatric diseases that could interfere with the aim of the study; malignant neoplasia
- •6. Intake of any drug affecting the cytochrome P450 for 28 days before the first dose
- •7. Any hormonal replacement therapy (estrogen-progestin formulations) within 4 weeks, any sex hormone depot injection within 6 months and any sex hormone implants within 5 years
Investigators
Similar Trials
Completed
Not Applicable
Bioavailability study of a new testosterone tablet formulation administered as single doses of 1, 2 and 3 mg to healthy postmenopausal womeISRCTN46559299IBSA Institut Biochimique SA16
Completed
Phase 1
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal WomenFemale Sexual DysfunctionNCT01364623Acerus Pharmaceuticals Corporation24
Completed
Not Applicable
Examination of the usefulness of testosterone cream for Late Onset Hypogonadism syndromeOH SyndromeJPRN-UMIN000029540Chibanisi-General Hospital200
Completed
Phase 2
Oral T7 Oral Testosterone in ManHealthy MalesMale ContraceptiveNCT00842751University of Washington11
Completed
Not Applicable
Administration study on preparation of testosterone undecanoate to healthy adult malesJPRN-jRCT1071210006Yonemura Takuma8
