Post-menopausal PeriodPhase 1NCT02667561
Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%
A Phase 1 study testing Testosterone gel 1% 2.2 mg, Testosterone gel 1% 4.4 mg and Testosterone gel 1% 8.8 mg in people with Post-menopausal Period, run by Biolab Sanus Farmaceutica.
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 Read more about this study
- Who is it for?
- Ages 42 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-menopausal Period
- What is being tested?
- Testosterone gel 1% 2.2 mg, Testosterone gel 1% 4.4 mg and Testosterone gel 1% 8.8 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
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.
- Conditions
- Post-menopausal Period
- Being tested
- Testosterone gel 1% 2.2 mg, Testosterone gel 1% 4.4 mg, Testosterone gel 1% 8.8 mg, Placebo of Testosterone Gel 1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gel 1% 2.2 mgDrug
Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Testosterone gel 1% 4.4 mgDrug
Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Testosterone gel 1% 8.8 mgDrug
Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebo of Testosterone Gel 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics, area under the curve (AUC)
Measured: 28 days
Pharmacokinetics, maximum concentration (Cmax)
Measured: 28 days
Pharmacokinetics, time to maximum concentration (Tmax)
Measured: 28 days
Pharmacokinetics, half-life (t1/2)
Measured: 28 days
Secondary outcomes (2)
Pharmacodynamics, response rate, by Female Sexual Function Index
Measured: 28 days
Safety, number of adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Study has been cancelled and it has not been initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopausal PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilberto De Nucci, PhD, Principal investigator, Galeno Desenvolvimento de Pesquisas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667561
- Sponsor's protocol ID
- GDN 060/15
- Status last verified
- Sep 2017
- First submitted
- 26 Jan 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02667561
- Acronym / sponsor ID
- GDN 060/15
- Conditions
- Post-menopausal Period
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been cancelled and it has not been initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Testosterone gel 1% 2.2 mg | Experimental | Drug: Testosterone gel 1% 2.2 mgTestosterone gel 1% Topical use 2.2 mg (220 mg of gel) once daily duration of treatment: 28 days |
| Testosterone gel 1% 4.4 mg | Experimental | Drug: Testosterone gel 1% 4.4 mgTestosterone gel 1% Topical use 4.4 mg (440 mg of gel) once daily duration of treatment: 28 days |
| Testosterone gel 1% 8.8 mg | Experimental | Drug: Testosterone gel 1% 8.8 mgTestosterone gel 1% Topical use 8.8 mg (880 mg of gel) once daily duration of treatment: 28 days |
| Placebo of Testosterone Gel 1% | Placebo comparator | Drug: Placebo of Testosterone Gel 1%Placebo of Testosterone Gel 1% Topical use Approximately 550 mg of gel Once daily duration of treatment: 28 days |
Who may qualify
- Ages
- 42 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone gel 1% 2.2 mgApplication of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days. | Drug | Testosterone gel 1% 2.2 mg |
| Testosterone gel 1% 4.4 mgApplication of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days. | Drug | Testosterone gel 1% 4.4 mg |
| Testosterone gel 1% 8.8 mgApplication of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days. | Drug | Testosterone gel 1% 8.8 mg |
| 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. | Drug | Placebo of Testosterone Gel 1% |
Primary outcome
Pharmacokinetics, area under the curve (AUC)
Time frame: 28 days
Pharmacokinetics, maximum concentration (Cmax)
Time frame: 28 days
Pharmacokinetics, time to maximum concentration (Tmax)
Time frame: 28 days
Pharmacokinetics, half-life (t1/2)
Time frame: 28 days
2 secondary outcomes
Pharmacodynamics, response rate, by Female Sexual Function Index
Time frame: 28 days
Safety, number of adverse events
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilberto De Nucci, PhD principal investigator
Galeno Desenvolvimento de Pesquisas
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone gel 1% 2.2 mg, Testosterone gel 1% 4.4 mg and Testosterone gel 1% 8.8 mg in people with Post-menopausal Period, run by Biolab Sanus Farmaceutica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics, area under the curve (AUC) (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.