Sexual Arousal DisorderPhase 2NCT02570282
Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder
A Phase 2 study testing SST-6007 in people with Sexual Arousal Disorder, run by Strategic Science & Technologies, LLC at 1 site in United States.
Trial summary
This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A sufficient number of participants will be enrolled to yield 30 (approximately 15 pre-menopausal and 15 post-menopausal) participants to complete… Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Sexual Arousal Disorder
- What is being tested?
- SST-6007
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2017
- Phase
- Phase 2
- 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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-menopausal women (surgically induced or natural) must meet 1 of the following criteria:
- Surgical oophorectomy, partial hysterectomy, or full hysterectomy at least 1 year prior to screening (self-report).
- No spontaneous menses >1 year (self-report).
- Post-menopausal participants, who are not on any hormone replacement therapies (HRT), must have a serum follicle-stimulating hormone (FSH) lab result >40mIU/mL.
- Women of childbearing potential must agree to continue using an appropriate form of birth control from Visit 1 through 7 days following the completion of Visit 3. Acceptable forms of birth control include the use of an IUD or hormonal therapy (oral, patch, etc.). Contraceptive foams/gels or condoms are not considered acceptable methods of birth control in this study. Participants must be on a stable dose for at least 6 months prior to Visit 1.
- Participant has a body mass index (BMI) from 18 to 30 kg/m², inclusive.
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- Participant is heterosexual.
- Participant has a normal electrocardiogram at Visit 1.
- Participant is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
- Participant must agree to not use vaginal or vulvar lubricants, spermicides, creams or gels, contraceptive foams or vaginal douche products from Visit 1 until the completion of Visit 3 9 Participant agrees to not engage in strenuous, unaccustomed exercise within 6 hours of visit 2 or visit 3.
Who cannot join
- Participant is nursing or pregnant (based on positive serum pregnancy test), or wishes to become pregnant during the study period.
- Participant has any disorder or a history of any disorder that may prevent the successful completion of the study in the opinion of the Sub-Investigator.
- Participant has used any topical hormone replacement therapy (HRT) applied locally to the genitals in the past three months. Oral and patch form of HRT are acceptable, as long as the participant reports being on a stable dose for at least 6 months prior to Visit 1.
- Participant has a significant cardiovascular, hepatic, metabolic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, or psychiatric disease or other unstable medical condition that would contraindicate administration of study medication, interfere with study evaluation, limit study participation, or confound the interpretation of study results in the opinion of the Sub-Investigator.
- Participant had an active ulcer or clinically significant bleeding disorder.
- Participant has a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to Visit 1; or any history of coronary disease causing angina; or congestive heart failure requiring medical intervention.
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- Participant has retinitis pigmentosa or sickle cell anemia or related anemias, even if the participant feels clinically well at the time of Visit 1. Participants with retinitis pigmentosa will be identified by specifically asking whether they have the condition, if there are visual signs and symptoms of the condition (including questioning participants as to whether they have difficulty seeing at night or in low light, and if they have any visual field deficits that indicate a loss of peripheral or central vision), or if there is a family history.
- 8 Participant has a history of orthostatic hypotension or orthostatic hypotension which is present at Visit 1, defined as a drop in systolic blood pressure ≥ 20 mm Hg, a drop in diastolic blood pressure ≥ 10 mm Hg or experiencing lightheadedness or dizziness at 1 or 3 minutes after the change in position from supine to standing.
- 9. Participant has primary anorgasmia, vaginismus, or sexual aversion disorder.
- 10. Participant has dyspareunia.
- 11. Participant has type 1 or type 2 diabetes.
- 12. Participant has undergone major pelvic surgery that may have caused nerve damage, including, vulvectomy, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
- 13. Participant has current and/or previous reported diagnoses of DSM-IV-TR axis I disorders including organic mental syndromes and disorders (e.g., schizophrenia, bipolar disorder, depression).
- 14. Participant has a history of cancer, other than basal cell carcinoma.
- 15. Participant has any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article in the opinion of the Sub-Investigator.
- 16. Participant has a history of non-arteritic ischemic optic neuropathy (NAION).
- 17. Participant has positive findings from the urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates).
- 18. Participant has positive serologic findings for sexually transmitted infection (syphilis, gonorrhea, chlamydia), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
- 19. Participant has moderate to severe current vaginitis, a vaginal infection including bacterial vaginosis or a yeast infection. The diagnosis of yeast infections should be made by the Sub-Investigator based on the physical and gynecological exams; the objective is to exclude women that are symptomatic. If the woman is not complaining of symptoms but the Sub-Investigator observes discharge, than the vaginal wet mount test should also be performed to confirm a diagnosis of yeast infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sexual Psychophysiology Laboratory
Austin, Texas, 78712
About this study
Official title: A Phase 2A, Single-Dose, Double-Blind Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder
This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A sufficient number of participants will be enrolled to yield 30 (approximately 15 pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).
Read the detailed description
Participants will first complete a telephone screen (< 28 days prior to Visit 1, Medical Screening) and will be scheduled for Visit 1 if eligible. After consent is obtained, study participants will undergo Visit 1 at a local gynecology clinic to determine their eligibility for continued study participation.
If the participant meets all of the inclusion criteria and none of the exclusion criteria, they will be scheduled for Visit 2 and Visit 3 of the SST-6007/Placebo Double-Blind, Dosing Phase to be conducted at the Sexual Psychophysiology Laboratory at the University of Texas at Austin. Visit 2 must be within 5 (±2) days of Visit 1. One visit will evaluate the participant's response to SST-6007 and the other will evaluate the participant's response to placebo cream, using the VPP, the Arousometer, and neutral-erotic film presentations. The sequence of dosing will be randomly assigned (i.e., placebo cream then SST-6007 or SST-6007 then placebo cream) according to a computer-generated, randomization. There will be a 4-8 day washout period between Visits 2 and 3.
During each experimental session, physiological and subjective sexual arousal will be assessed simultaneously and continuously using the VPP and the Arousometer. Electrical activity of the heart will be assessed with an ECG. ECG data will be used to process the VPA data. Immediately following completion of each erotic film, subjective sexual arousal, subjective perception of genital arousal, and positive and negative affect will be evaluated using a self-report 7-point Likert Scale (Film Scale) and the Positive and Negative Affect Schedule (PANAS).
- Conditions
- Sexual Arousal Disorder
- Being tested
- Placebo, SST-6007
- Keywords
- Female
- 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.
PlaceboDrug
Approximately 50% of the cream is to be applied externally to the clitoris and labia minora and approximately 50% is to be applied intravaginally.
SST-6007Drug
SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate Receives: Drug: SST-6007 |
| Placebo | Placebo comparator | Placebo IP will be the same as SST-6007 without the active ingredient, sildenafil citrate. It will be matched in appearance, smell, consistency, and color to SST-6007 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-reported levels of subjective sexual arousal measured continuously by the Arousometer
Measured on a 1-7 numeric scale evey 2 seconds
Measured: 1 hour
Physiological genital response in women with FSAD assessed using the vaginal photoplethysmograph (VPP)
Measured on a 1-10 scale by electrical impulse 6 times a second
Measured: 1 hour
Secondary outcomes (1)
Adverse events and vital signs
Adverse events and vital signs
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Arousal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strategic Science & Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cindy Meston, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570282
- Sponsor's protocol ID
- SST-6007-02-01
- Status last verified
- Jan 2017
- First submitted
- 3 Oct 2015
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Single-Dose, Double-Blind Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder
- ClinicalTrials.gov ID
- NCT02570282
- Acronym / sponsor ID
- SST-6007-02-01
- Conditions
- Sexual Arousal Disorder
- Keywords
- Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Strategic Science & Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 Oct 2015 (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 2, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A sufficient number of participants will be enrolled to yield 30 (approximately 15 pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).
Detailed description
Participants will first complete a telephone screen (< 28 days prior to Visit 1, Medical Screening) and will be scheduled for Visit 1 if eligible. After consent is obtained, study participants will undergo Visit 1 at a local gynecology clinic to determine their eligibility for continued study participation.
If the participant meets all of the inclusion criteria and none of the exclusion criteria, they will be scheduled for Visit 2 and Visit 3 of the SST-6007/Placebo Double-Blind, Dosing Phase to be conducted at the Sexual Psychophysiology Laboratory at the University of Texas at Austin. Visit 2 must be within 5 (±2) days of Visit 1. One visit will evaluate the participant's response to SST-6007 and the other will evaluate the participant's response to placebo cream, using the VPP, the Arousometer, and neutral-erotic film presentations. The sequence of dosing will be randomly assigned (i.e., placebo cream then SST-6007 or SST-6007 then placebo cream) according to a computer-generated, randomization. There will be a 4-8 day washout period between Visits 2 and 3.
During each experimental session, physiological and subjective sexual arousal will be assessed simultaneously and continuously using the VPP and the Arousometer. Electrical activity of the heart will be assessed with an ECG. ECG data will be used to process the VPA data. Immediately following completion of each erotic film, subjective sexual arousal, subjective perception of genital arousal, and positive and negative affect will be evaluated using a self-report 7-point Likert Scale (Film Scale) and the Positive and Negative Affect Schedule (PANAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SST-6007SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo IP will be the same as SST-6007 without the active ingredient, sildenafil citrate. It will be matched in appearance, smell, consistency, and color to SST-6007 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Post-menopausal women (surgically induced or natural) must meet 1 of the following criteria:
- Post-menopausal participants, who are not on any hormone replacement therapies (HRT), must have a serum follicle-stimulating hormone (FSH) lab result >40mIU/mL.
- Women of childbearing potential must agree to continue using an appropriate form of birth control from Visit 1 through 7 days following the completion of Visit 3. Acceptable forms of birth control include the use of an IUD or hormonal therapy (oral, patch, etc.). Contraceptive foams/gels or condoms are not considered acceptable methods of birth control in this study. Participants must be on a stable dose for at least 6 months prior to Visit 1.
- Participant has a body mass index (BMI) from 18 to 30 kg/m², inclusive.
- Participant is heterosexual.
Key exclusion criteria (19 listed)
- Participant is nursing or pregnant (based on positive serum pregnancy test), or wishes to become pregnant during the study period.
- Participant has any disorder or a history of any disorder that may prevent the successful completion of the study in the opinion of the Sub-Investigator.
- Participant has used any topical hormone replacement therapy (HRT) applied locally to the genitals in the past three months. Oral and patch form of HRT are acceptable, as long as the participant reports being on a stable dose for at least 6 months prior to Visit 1.
- Participant has a significant cardiovascular, hepatic, metabolic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, or psychiatric disease or other unstable medical condition that would contraindicate administration of study medication, interfere with study evaluation, limit study participation, or confound the interpretation of study results in the opinion of the Sub-Investigator.
- Participant had an active ulcer or clinically significant bleeding disorder.
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 |
|---|---|---|
| PlaceboApproximately 50% of the cream is to be applied externally to the clitoris and labia minora and approximately 50% is to be applied intravaginally. | Drug | Placebo |
| SST-6007SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate | Drug | Sildenafil |
Primary outcome
Participant-reported levels of subjective sexual arousal measured continuously by the Arousometer
Time frame: 1 hour
Measured on a 1-7 numeric scale evey 2 seconds
Physiological genital response in women with FSAD assessed using the vaginal photoplethysmograph (VPP)
Time frame: 1 hour
Measured on a 1-10 scale by electrical impulse 6 times a second
1 secondary outcome
Adverse events and vital signs
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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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.
Cindy Meston, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SST-6007 in people with Sexual Arousal Disorder, run by Strategic Science & Technologies, 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 10 inclusion and 19 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 3 Oct 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant-reported levels of subjective sexual arousal measured continuously by the Arousometer (time frame: 1 hour). The study lists 2 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 3 Oct 2017.