Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

NCT02667561 | Withdrawn Phase 1

• 1 other identifier: GDN 060/15
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Post-menopausal Period

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Pharmacodynamics, response rate, by Female Sexual Function Index

  28 days

• Safety, number of adverse events

  28 days

Study Arms (4)

Testosterone gel 1% 2.2 mg

EXPERIMENTAL

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

Testosterone gel 1% 4.4 mg

EXPERIMENTAL

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

Testosterone gel 1% 8.8 mg

EXPERIMENTAL

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

Placebo of Testosterone Gel 1%

PLACEBO COMPARATOR

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%

Interventions

Testosterone gel 1% 2.2 mg DRUG

Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Testosterone gel 1% 2.2 mg

Testosterone gel 1% 4.4 mg DRUG

Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Testosterone gel 1% 4.4 mg

Testosterone gel 1% 8.8 mg DRUG

Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Testosterone gel 1% 8.8 mg

Placebo of Testosterone Gel 1% DRUG

Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Placebo of Testosterone Gel 1%

Eligibility Criteria

• Age: 42 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

Study Officials

• Gilberto De Nucci, PhD

  Galeno Desenvolvimento de Pesquisas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: July 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: June 6, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share