Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

Post-menopausal Period Clinical Trial

Official title:

Phase I Clinical Trial for Evaluation of Pharmacokinetics, Pharmacodynamics and Safety of Testosterone Gel 1% for Topical Use, After Administration of Three Different Doses (2.2 mg, 4.4 mg, 8.8 mg and Placebo) for 28 Consecutive Days in Post-menopausal Women.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02667561
• Other study ID #: GDN 060/15
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 2017
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: Biolab Sanus Farmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days

Description:

This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, Study participants will receive investigational product for 28 consecutive days, once daily, as per the following allocation: 2.2 mg, 4.4 mg. 8.8 mg or placebo.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female subjects aged = 42 years and = 65 years, in post-menopausal period for at least 1 year and with active sexual life;

• Serum testosterone levels < 33 ng/mL;

• Follicle-stimulating hormone (FSH) levels > 22 mU/mL;

• Absence of other significant diseases which, at the physician's discretion, could impact subject's participation in the trial, according to protocol requirements, and study evaluations: medical history, blood pressure and heart rate measurements, physical examination and complimentary laboratory tests;

• Ability to understand the nature and objective of the trial, including risks and adverse events, which shall be confirmed by Informed Consent Form signature.

Exclusion Criteria:

• Screening laboratory tests results presenting clinically relevant deviations that, at the investigator discretion, prevent the subject to participate in the trial due to possible risks;

• Drugs addiction, including alcohol;

• Treatment with any drugs known to have a well-established toxic potential to major organs, within 3 months before the trial, ;

• Participation in any other experimental research or administration of any experimental drug within six months before the initiation of this trial;

• Pregnancy, labor or miscarriage in the last 12 weeks before the antecipated date of the study treatment start;

• Any conditions, according to investigator's best judgement, that prevents the subject to participate in the trial.

Related Conditions & MeSH terms

• Post-menopausal Period

Intervention

Drug:
• Testosterone gel 1% 2.2 mg
Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
• Testosterone gel 1% 4.4 mg
Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
• Testosterone gel 1% 8.8 mg
Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
• Placebo of Testosterone Gel 1%
Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biolab Sanus Farmaceutica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics, area under the curve (AUC)		28 days
Primary	Pharmacokinetics, maximum concentration (Cmax)		28 days
Primary	Pharmacokinetics, time to maximum concentration (Tmax)		28 days
Primary	Pharmacokinetics, half-life (t1/2)		28 days
Secondary	Pharmacodynamics, response rate, by Female Sexual Function Index		28 days
Secondary	Safety, number of adverse events		28 days