Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

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.

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

Study Overview

• Status: Withdrawn
• Conditions: Post-menopausal Period
• Intervention / Treatment: Drug: Testosterone gel 1% 2.2 mg; Drug: Testosterone gel 1% 4.4 mg; Drug: Testosterone gel 1% 8.8 mg; Drug: Placebo of Testosterone Gel 1%

Detailed 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.

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Testosterone gel 1% 2.2 mg; Testosterone gel 1% Topical use 2.2 mg (220 mg of gel) once daily duration of treatment: 28 days	Drug: Testosterone gel 1% 2.2 mg; Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Experimental: Testosterone gel 1% 4.4 mg; Testosterone gel 1% Topical use 4.4 mg (440 mg of gel) once daily duration of treatment: 28 days	Drug: Testosterone gel 1% 4.4 mg; Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Experimental: Testosterone gel 1% 8.8 mg; Testosterone gel 1% Topical use 8.8 mg (880 mg of gel) once daily duration of treatment: 28 days	Drug: Testosterone gel 1% 8.8 mg; Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Placebo Comparator: Placebo of Testosterone Gel 1%; Placebo of Testosterone Gel 1% Topical use Approximately 550 mg of gel Once daily duration of treatment: 28 days	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics, area under the curve (AUC)	28 days
Pharmacokinetics, maximum concentration (Cmax)	28 days
Pharmacokinetics, time to maximum concentration (Tmax)	28 days
Pharmacokinetics, half-life (t1/2)	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamics, response rate, by Female Sexual Function Index	28 days
Safety, number of adverse events	28 days

Collaborators and Investigators

• Sponsor: Biolab Sanus Farmaceutica
• Investigators: Principal Investigator: Gilberto De Nucci, PhD, Galeno Desenvolvimento de Pesquisas

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: GDN 060/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No