Female Sexual DysfunctionPhase 1NCT01364623
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
A Phase 1 study testing Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose and High dose testosterone nasal gel, single dose in people with Female Sexual Dysfunction, run by Acerus Pharmaceuticals Corporation at 1 site in United States.
Trial summary
The purpose of this study was to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose and High dose testosterone nasal gel, single dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects having regular menstrual cycles between 26-32 days.
- Women of childbearing potential must agree to use one of the following reliable birth control methods prior to the study, during the study and up until one month after the end of the study:
- Surgically sterile
- Intrauterine device in place for at least 3 months prior to study initiation
- Barrier method (condom with spermicidal agent use by partner)
- Abstinence
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- Negative for drugs of abuse, hepatitis B-surface antigen, hepatitis C, HIV, and pregnancy (serum ß-HCG).
- Body Mass Index greater than or equal to 18.5 kg/m² and less than or equal to 35 kg/m².
- Subjects with a normal ENT exam.
- Subjects with normal TSH values.
- No clinically significant findings in the physical examination, 12-lead ECG and vital signs
- Normal thyroid function. Physiological prolactin concentration.
- All clinical laboratory test values within the acceptable ranges (any clinically significant findings will require investigator/sponsor approval)
- Able to understand and provide written informed consent.
- Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF
Who cannot join
- Known history of hypersensitivity to Testosterone (e.g. Intrinsa patch) and/or related drugs.
- Known history of polycystic ovarian syndrome.
- Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, psychiatric, hematological, reproductive, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.
- Presence of or known history of Estrogen-responsive tumors such as breast cancer and /or history of any cancer, excluding basal cell carcinoma.
- Known history of frequent clinically significant acne.
- Known history of hirsutism
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- History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, "nose job", or sinus surgery.
- Prior nasal fractures.
- Active allergies, such as rhinitis, rhinorrhea, and nasal congestion.
- Mucosal inflammatory disorders, specifically pemphigus, and Sjogren's syndrome.
- Sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis.
- History of nasal disorders or sleep apnea.
- Use of any form of intra-nasal medication delivery, specifically nasal corticosteroids and oxymetazoline containing nasal sprays
- History of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies.
- Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any history of drug abuse or alcohol abuse as per DSM-IV criteria within 6 months of study drug administration.
- Current treatment with any hormone replacement therapy within previous 12 months, treatment with drugs which interfere with metabolism of Testosterone within 30 days of study drug administration and/or any other prescription medications. Difficulty in abstaining from OTC medication for the duration of study.
- Use of oral, transdermal and implant contraceptives within 30 days prior to drug administration or a depot contraceptives injection within one year prior to drug administration.
- Evidence of pregnancy or lactation.
- Subjects who are breast feeding or have breast fed within the last six (6) months prior to the Screening Visit.
- Administration of another investigational drug within 30 days prior to study medication administration.
- Blood donation within 56 days prior to study medication administration.
- Any participation as a plasma donor in a plasmapheresis program within seven days preceding screening in this study.
- Intolerance to venipuncture.
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
- History of Deep Venous Thrombosis or coagulation disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Premier Research International LLC
Austin, Texas, 78705
About this study
Official title: An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels
The purpose of this study was to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2.
In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG and estradiol through pharmacokinetic profiles was also conducted.
Read the detailed description
This is a 2 Period study that requires overnight stays in clinic. Blood samples are required at all visits including sampling at predefined time periods during the overnight stays.
Period I
Subjects were checked-in on Day 1 Period I to start their baseline testosterone measurement (dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They remained institutionalized until Day 4 morning, and were checked out after the 48 hour blood draw and study close-out for those that did not continue with Period II.
Period II (Multi-Dose)
At the end of Period 1, a total of 8 subjects sampled from these 3 cohorts, who were willing and able to continue with the multiple-dose portion of the study were selected to participate in Period 2. Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3, and were checked out after the 48 hour blood draw and study close-out.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose, High dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, multiple dose
- Keywords
- testosterone, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose testosterone nasal gel, single doseDrug
Also called TBS-2
Low dose testosterone nasal gel, single dose
Medium dose testosterone nasal gel, single doseDrug
Also called TBS-2
Medium dose testosterone nasal gel, single dose
High dose testosterone nasal gel, single doseDrug
Also called TBS-2
High dose testosterone nasal gel, single dose
Medium dose testosterone nasal gel, multiple doseDrug
Also called TBS-2
Medium dose testosterone nasal gel, multiple dose
| Study group | Role | What they receive |
|---|---|---|
| Low dose TBS-2 single dose | Experimental | TBS-2 dispensers prefilled with 0.24% testosterone gel to deliver a single dose of 300 μg of testosterone per nostril, for a total dose of 600 μg given at 0800 hours (±30 minutes) on Day 2 of Period 1 for Cohort 1 (Low dose testosterone nasal gel, single dose) Receives: Drug: Low dose testosterone nasal gel, single dose |
| Medium dose TBS-2 single dose | Experimental | TBS-2 dispensers prefilled with 0.48% testosterone gel to deliver a single dose of 600 μg of testosterone per nostril, for a total dose of 1200 μg given at 0800 hours (±30 minutes) on Day 2 of Period 1 for Cohort 2 (Medium dose testosterone nasal gel, single dose) Receives: Drug: Medium dose testosterone nasal gel, single dose |
| High dose TBS-2 single dose | Experimental | TBS-2 dispensers prefilled with 0.72% testosterone gel to deliver a single dose of 900 μg of testosterone per nostril, for a total dose of 1800 μg given at 0800 hours (±30 minutes) on Day 2 of Period 1 for Cohort 3 (High dose testosterone nasal gel, single dose) Receives: Drug: High dose testosterone nasal gel, single dose |
| Medium dose TBS-2 multiple doses | Experimental | TBS-2 dispensers prefilled with 0.48% testosterone gel to deliver a single dose of 600 μg of testosterone per nostril, for a total dose of 1200 μg given t.i.d. daily at 0800 hours (± 30 minutes), 1600 hours (± 30 minutes), and 2400 hours (± 30 minutes) on Days 1 and 2 of Period 2, and once in the morning at 0800 hours (± 30 minutes) on Day 3 of Period 2 (Multi-dose group) (Medium dose testosterone nasal gel, multiple dose) Receives: Drug: Medium dose testosterone nasal gel, multiple dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability (AUC0-t) of Total Testosterone Through Pharmacokinetic (PK) Profiles
Area under the concentration time curve from time zero to the last measurable concentration time point (AUC0-t) for single dose and AUCtau shown for multiple dose.
Measured: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Bioavailability (Cmax) of Total Testosterone Through Pharmacokinetic Profiles
Cmax - maximum concentration of total testosterone observed after dosing of TBS-2
Measured: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Medium Dose TBS-2 Multiple Dose Average Steady-state Concentration (Cavg) of Total Testosterone
Measured: -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48h after Day 3 dosing
Secondary outcomes (2)
Area Under the Plasma Concentration Versus Time Curve (AUC) for Dihydrotestosterone Following TBS-2
AUCt shown for single dose and AUCtau for multiple dose.
Measured: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Area Under the Plasma Concentration Versus Time Curve (AUC) for Estradiol Following TBS-2
AUCt shown for single dose and AUCtau for multiple dose.
Measured: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Sexual DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerus Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Tkachenko, MD, Study director, Trimel Pharmaceuticals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364623
- Sponsor's protocol ID
- TBS-2-2011-01
- Status last verified
- Oct 2019
- First submitted
- 27 May 2011
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels
- ClinicalTrials.gov ID
- NCT01364623
- Acronym / sponsor ID
- TBS-2-2011-01
- Conditions
- Female Sexual Dysfunction
- Keywords
- testosterone, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2.
In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG and estradiol through pharmacokinetic profiles was also conducted.
Detailed description
This is a 2 Period study that requires overnight stays in clinic. Blood samples are required at all visits including sampling at predefined time periods during the overnight stays.
Period I
Subjects were checked-in on Day 1 Period I to start their baseline testosterone measurement (dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They remained institutionalized until Day 4 morning, and were checked out after the 48 hour blood draw and study close-out for those that did not continue with Period II.
Period II (Multi-Dose)
At the end of Period 1, a total of 8 subjects sampled from these 3 cohorts, who were willing and able to continue with the multiple-dose portion of the study were selected to participate in Period 2. Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3, and were checked out after the 48 hour blood draw and study close-out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose TBS-2 single dose | Experimental | Drug: Low dose testosterone nasal gel, single doseTBS-2 dispensers prefilled with 0.24% testosterone gel to deliver a single dose of 300 μg of testosterone per nostril, for a total dose of 600 μg given at 0800 hours (±30 minutes) on Day 2 of Period 1 for Cohort 1 (Low dose testosterone nasal gel, single dose) |
| Medium dose TBS-2 single dose | Experimental | Drug: Medium dose testosterone nasal gel, single doseTBS-2 dispensers prefilled with 0.48% testosterone gel to deliver a single dose of 600 μg of testosterone per nostril, for a total dose of 1200 μg given at 0800 hours (±30 minutes) on Day 2 of Period 1 for Cohort 2 (Medium dose testosterone nasal gel, single dose) |
| High dose TBS-2 single dose | Experimental | Drug: High dose testosterone nasal gel, single doseTBS-2 dispensers prefilled with 0.72% testosterone gel to deliver a single dose of 900 μg of testosterone per nostril, for a total dose of 1800 μg given at 0800 hours (±30 minutes) on Day 2 of Period 1 for Cohort 3 (High dose testosterone nasal gel, single dose) |
| Medium dose TBS-2 multiple doses | Experimental | Drug: Medium dose testosterone nasal gel, multiple doseTBS-2 dispensers prefilled with 0.48% testosterone gel to deliver a single dose of 600 μg of testosterone per nostril, for a total dose of 1200 μg given t.i.d. daily at 0800 hours (± 30 minutes), 1600 hours (± 30 minutes), and 2400 hours (± 30 minutes) on Days 1 and 2 of Period 2, and once in the morning at 0800 hours (± 30 minutes) on Day 3 of Period 2 (Multi-dose group) (Medium dose testosterone nasal gel, multiple dose) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subjects having regular menstrual cycles between 26-32 days.
- Women of childbearing potential must agree to use one of the following reliable birth control methods prior to the study, during the study and up until one month after the end of the study:
- Negative for drugs of abuse, hepatitis B-surface antigen, hepatitis C, HIV, and pregnancy (serum ß-HCG).
- Body Mass Index greater than or equal to 18.5 kg/m² and less than or equal to 35 kg/m².
- Subjects with a normal ENT exam.
Key exclusion criteria (26 listed)
- Known history of hypersensitivity to Testosterone (e.g. Intrinsa patch) and/or related drugs.
- Known history of polycystic ovarian syndrome.
- Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, psychiatric, hematological, reproductive, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.
- Presence of or known history of Estrogen-responsive tumors such as breast cancer and /or history of any cancer, excluding basal cell carcinoma.
- Known history of frequent clinically significant acne.
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 |
|---|---|---|
| Low dose testosterone nasal gel, single doseAlso: TBS-2Low dose testosterone nasal gel, single dose | Drug | Low dose TBS-2 single dose |
| Medium dose testosterone nasal gel, single doseAlso: TBS-2Medium dose testosterone nasal gel, single dose | Drug | Medium dose TBS-2 single dose |
| High dose testosterone nasal gel, single doseAlso: TBS-2High dose testosterone nasal gel, single dose | Drug | High dose TBS-2 single dose |
| Medium dose testosterone nasal gel, multiple doseAlso: TBS-2Medium dose testosterone nasal gel, multiple dose | Drug | Medium dose TBS-2 multiple doses |
Primary outcome
Bioavailability (AUC0-t) of Total Testosterone Through Pharmacokinetic (PK) Profiles
Time frame: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Area under the concentration time curve from time zero to the last measurable concentration time point (AUC0-t) for single dose and AUCtau shown for multiple dose.
Bioavailability (Cmax) of Total Testosterone Through Pharmacokinetic Profiles
Time frame: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Cmax - maximum concentration of total testosterone observed after dosing of TBS-2
Medium Dose TBS-2 Multiple Dose Average Steady-state Concentration (Cavg) of Total Testosterone
Time frame: -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48h after Day 3 dosing
2 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC) for Dihydrotestosterone Following TBS-2
Time frame: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Area Under the Plasma Concentration Versus Time Curve (AUC) for Estradiol Following TBS-2
Time frame: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Natalia Tkachenko, MD study director
Trimel Pharmaceuticals Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose and High dose testosterone nasal gel, single dose in people with Female Sexual Dysfunction, run by Acerus Pharmaceuticals Corporation at 1 site in United States.
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 15 inclusion and 26 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: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bioavailability (AUC0-t) of Total Testosterone Through Pharmacokinetic (PK) Profiles (time frame: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing). The study lists 3 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 16 Oct 2019.