Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder

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).

Inclusion Criteria:

1. 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).

2. Post-menopausal participants, who are not on any hormone replacement therapies (HRT),
must have a serum follicle-stimulating hormone (FSH) lab result >40mIU/mL.

3. 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.

4. Participant has a body mass index (BMI) from 18 to 30 kg/m², inclusive.

5. Participant is heterosexual.

6. Participant has a normal electrocardiogram at Visit 1.

7. Participant is capable of understanding and complying with the protocol and agrees to
sign the informed consent document.

8. 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.

Exclusion Criteria:

1. Participant is nursing or pregnant (based on positive serum pregnancy test), or wishes
to become pregnant during the study period.

2. 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.

3. 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.

4. 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.

5. Participant had an active ulcer or clinically significant bleeding disorder.

6. 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.

7. 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.