Bioavailability study of a new testosterone orodispersible tablet (ODT) administered as single doses of 6 and 12 mg to healthy postmenopausal wome

Phase 1

Completed

• Conditions: Healthy adult volunteers under fasting conditions; Not Applicable

• Registration Number: ISRCTN13049111
• Lead Sponsor: IBSA Institut Biochimique S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-10-07
• Study Start: 2015-10-16
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline-corrected rate (Cmax) and extent (AUC0-t) of exposure of total testosterone, free-testosterone and 5a-dihydro-testosterone (DHT) after single dose administration of the test treatments at baseline, 10, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post-dose

Secondary Outcome Measures

Name	Time	Method
<br> 1. tmax and baseline-corrected AUC0-8, t1/2, and ?z of total testosterone, free-testosterone and DHT at baseline, 10, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post-dose<br> 2. Treatment-Emergent Adverse Events (TEAEs), vital signs (BP, HR), body weight, laboratory parameters (hormones included), ECG after administration of each test treatment.<br>