Hypoactive Sexual Desire DisorderPhase 1NCT01096329
A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®
A Phase 1 study testing Testosterone Spray 5% and 1%, Intrinsa® Patch and Testosterone Spray 5% and Intrinsa® Patch and Testosterone Spray 1% in people with Hypoactive Sexual Desire Disorder, run by VIVUS LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Testosterone Spray 5% and 1%, Intrinsa® Patch and Testosterone Spray 5% and Intrinsa® Patch and Testosterone Spray 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2010
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent
- Naturally or surgically postmenopausal females, 45 - 65 years of age
- Subjects have spontaneous amenorrhea for at least 12 months
- Subjects have a serum total testosterone level of < 30 ng/dL
- Subjects currently on a stable dose of prescribed oral or transdermal estrogen replacement therapy (ERT) for a period of at least 8 to 12 weeks prior to screening, respectively, or not on ERT.
- A body weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive [BMI will be calculated as weight in kg/(height in m)2]
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- Medically healthy, with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examination (including breast examination), in the opinion of the Investigator.
- Subjects are able to communicate with the Investigator, and to understand and to comply with all requirements of study participation.
- An adequate washout period prior to obtaining any baseline assessments in women who have been previously treated for postmenopausal symptoms. Calculated from study Day 1, the minimum washout period will be 2 and 4 weeks for prior treatment with testosterone oral and transdermal products, respectively, 3 months for prior treatment with testosterone implants and 2 weeks for treatment with estratest.
Who cannot join
- A positive serum pregnancy test at screening
- A history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the transdermal absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator
- Any clinically significant laboratory abnormalities as judged by the Investigator
- Subjects are experiencing > 20 hot flushes per week
- Subjects are suffering from severe acne, moderate to severe hirsutism or androgenic alopecia, or have a history of severe dermatological problems or drug-induced contact dermatitis
- Systolic blood pressure > 150 mm Hg or diastolic blood pressure > 95 mm Hg at screening or prior to the first dosing in this study (two rechecks are allowed)
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- Any malignancy except basal cell carcinoma
- A significant psychiatric disorder (e.g., major depression, etc.) that might, in the Investigator's opinion, prevent the subject from completing the study
- Currently smoke more than 10 cigarettes a day
- A history of breast biopsy with atypical hyperplasia
- A prior history of breast cancer, suspected breast cancer, or other current or prior cancer within the past 10 years
- Exhibits anemia, defined as a hemoglobin level at screening below the laboratory's lower limit of normal reference range
- Diabetes mellitus
- Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessments of skin tolerability
- Positive urine drug test and/or positive breath alcohol test at screening or prior to the first dosing in this study (Period 1 only)
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening
- Any history or presence of alcoholism or drug or substance abuse as defined by the Investigator
- A history of hypersensitivity or idiosyncratic reaction to testosterone, octisalate, PEG 200, IPA, or other sunscreens, or alcohol-based skin products or Intrinsa®
- Use of any prescription (except estrogen replacement therapy) or over-the-counter (OTC) medication, within the 30 days prior to the first dosing in this study. Up to 2 g per day of acetaminophen is allowed at the discretion of the Investigator
- Use of any drugs known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism [CYP P450]) within 30 days prior to the first dosing in this study. Use of any systemic corticosteroids within 30 days prior to the first dosing in this study
- Blood donation or significant blood loss within 56 days prior to the first dosing in this study. Any contraindication to blood sampling
- Plasma donation within 7 days prior to the first dosing in this study
- Currently using or has a history of any androgen use within 6 months prior to screening, or uses dehydroepiandrosterone (DHEA) >/= 25 mg per day, or St. John's Wort within 4 weeks prior to baseline. Due to large number of herbal remedies available, all other herbal supplements will be reviewed by the Sponsor during screening
- Currently using estratest (esterified estrogens and methyltestosterone)
- Use of an investigational drug within 30 days or six half-lives, whichever is longer, prior to the first dosing in this study
- Clinical judgment by the Investigator that the subject should not participate in the study
- Involvement in the planning and conduct of the study (applies to both VIVUS and designee staff, and staff at the investigational site)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Three-cohort, Two-period Crossover Study to Determine the Relative Bioavailability of Testosterone Following Application of Two Testosterone Transdermal Spray (TTS) Formulations Once Daily and Intrinsa® Patch Twice Weekly in Healthy, Surgically and Naturally Post-menopausal Women Receiving Estrogen Replacement Therapy
The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Testosterone Spray 5% and 1%, Intrinsa® Patch and Testosterone Spray 5%, Intrinsa® Patch and Testosterone Spray 1%
- Keywords
- postmenopausal, hormone replacement therapy
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Spray 5% and 1%Drug
Testosterone Spray 5% 2x90uL for 14 days Testosterone Spray 1% 2x90uL for 14 days
Intrinsa® Patch and Testosterone Spray 5%Drug
Testosterone Spray 5% 2x90uL for 14 days Intrinsa® Patch for 14 days
Intrinsa® Patch and Testosterone Spray 1%Drug
Testosterone Spray 1% 2x90uL for 14 days Intrinsa® Patch for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 | Active comparator | Testosterone Spray (5%) vs Intrinsa® Patch Receives: Drug: Intrinsa® Patch and Testosterone Spray 5% |
| Cohort 3 | Active comparator | Testosterone Spray (1%) vs Intrinsa® Patch Receives: Drug: Intrinsa® Patch and Testosterone Spray 1% |
| Cohort 1 | Active comparator | Testosterone Spray (5%) vs Testosterone Spray (1%) Receives: Drug: Testosterone Spray 5% and 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the amount of testosterone in the blood after dosing
The following PK parameters of testosterone will be measured AUC0-24, AUC0-48, AUC0-72, AUC0-96, Cavg, Cmin, Cmax
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Allison, MD, Principal investigator, MDS Pharma Services Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096329
- Sponsor's protocol ID
- VTS-102
- Status last verified
- Jun 2011
- First submitted
- 28 Mar 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Three-cohort, Two-period Crossover Study to Determine the Relative Bioavailability of Testosterone Following Application of Two Testosterone Transdermal Spray (TTS) Formulations Once Daily and Intrinsa® Patch Twice Weekly in Healthy, Surgically and Naturally Post-menopausal Women Receiving Estrogen Replacement Therapy
- ClinicalTrials.gov ID
- NCT01096329
- Acronym / sponsor ID
- VTS-102
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- postmenopausal, hormone replacement therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- First posted
- 31 Mar 2010 (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.
The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | Active comparator | Drug: Intrinsa® Patch and Testosterone Spray 5%Testosterone Spray (5%) vs Intrinsa® Patch |
| Cohort 3 | Active comparator | Drug: Intrinsa® Patch and Testosterone Spray 1%Testosterone Spray (1%) vs Intrinsa® Patch |
| Cohort 1 | Active comparator | Drug: Testosterone Spray 5% and 1%Testosterone Spray (5%) vs Testosterone Spray (1%) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written Informed Consent
- Naturally or surgically postmenopausal females, 45 - 65 years of age
- Subjects have spontaneous amenorrhea for at least 12 months
- Subjects have a serum total testosterone level of < 30 ng/dL
- Subjects currently on a stable dose of prescribed oral or transdermal estrogen replacement therapy (ERT) for a period of at least 8 to 12 weeks prior to screening, respectively, or not on ERT.
Key exclusion criteria (27 listed)
- A positive serum pregnancy test at screening
- A history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the transdermal absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator
- Any clinically significant laboratory abnormalities as judged by the Investigator
- Subjects are experiencing > 20 hot flushes per week
- Subjects are suffering from severe acne, moderate to severe hirsutism or androgenic alopecia, or have a history of severe dermatological problems or drug-induced contact dermatitis
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 Spray 5% and 1%Testosterone Spray 5% 2x90uL for 14 days Testosterone Spray 1% 2x90uL for 14 days | Drug | Cohort 1 |
| Intrinsa® Patch and Testosterone Spray 5%Testosterone Spray 5% 2x90uL for 14 days Intrinsa® Patch for 14 days | Drug | Cohort 2 |
| Intrinsa® Patch and Testosterone Spray 1%Testosterone Spray 1% 2x90uL for 14 days Intrinsa® Patch for 14 days | Drug | Cohort 3 |
Primary outcome
To measure the amount of testosterone in the blood after dosing
Time frame: 2 months
The following PK parameters of testosterone will be measured AUC0-24, AUC0-48, AUC0-72, AUC0-96, Cavg, Cmin, Cmax
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
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.
Mark Allison, MD principal investigator
MDS Pharma Services Inc
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 Testosterone Spray 5% and 1%, Intrinsa® Patch and Testosterone Spray 5% and Intrinsa® Patch and Testosterone Spray 1% in people with Hypoactive Sexual Desire Disorder, run by VIVUS LLC 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 9 inclusion and 27 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: stopped early, as of the sponsor's last update on 8 Jun 2011. 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?
The study was stopped early. Results are not available in the source record.
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?
To measure the amount of testosterone in the blood after dosing (time frame: 2 months). 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 8 Jun 2011.