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WithdrawnNCT02667561Updated Jun 6, 2018

Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

A Phase 1 interventional study of Testosterone gel 1% 2.2 mg and Testosterone gel 1% 4.4 mg in Post-menopausal Period, sponsored by Biolab Sanus Farmaceutica. Withdrawn. Open to female participants aged 42 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Biolab Sanus Farmaceutica · Phase 1, Interventional, and Other

Why this study was withdrawn
Study has been cancelled and it has not been initiated.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
42 Years to 65 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Post-menopausal Period
03

In context

Lead sponsor

Biolab Sanus Farmaceutica is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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%

Interventions

  • DrugTestosterone gel 1% 2.2 mg

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

  • DrugTestosterone gel 1% 4.4 mg

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

  • DrugTestosterone gel 1% 8.8 mg

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

  • DrugPlacebo of Testosterone Gel 1%

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

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics, area under the curve (AUC)

    Time frame: 28 days

  2. Pharmacokinetics, maximum concentration (Cmax)

    Time frame: 28 days

  3. Pharmacokinetics, time to maximum concentration (Tmax)

    Time frame: 28 days

  4. Pharmacokinetics, half-life (t1/2)

    Time frame: 28 days

Secondary outcomes

  1. Pharmacodynamics, response rate, by Female Sexual Function Index

    Time frame: 28 days

  2. Safety, number of adverse events

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02667561
Lead sponsor
Biolab Sanus Farmaceutica
Responsible party
Sponsor
First posted
Jan 29, 2016
Start date
Jul 2017 (estimated)
Primary completion
Dec 2017 (estimated)
Completion
May 2018 (estimated)
Last update
Jun 6, 2018

Study contacts

Gilberto De Nucci, PhD
principal investigator · Galeno Desenvolvimento de Pesquisas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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