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DARÉ BIOSCIENCE, INC.

(DARE)
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Dare Bioscience : International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting 2020

03/09/2020 | 08:18am EST

Preliminary Efficacy of Sildenafil Cream,

3.6% During Female Sexual Arousal

Sue W. Goldstein, BA, CCRC, AASECT-CSE, IF1; Tuuli M. Kukkonen, PhD,

CPsych2 ; Adrianne Monsef, BA3 ; Irwin Goldstein, MD1

  1. San Diego Sexual Medicine, San Diego, CA; 2: University of Guelph, Guelph, Ontario; 3: Strategic Science and Technologies, LLC Cambridge, MA

ISSWSH 2020, Orlando, FL

Disclosures

Research supported by Daré Bioscience, commercial and development partner

to Strategic Science & Technologies, LLC (Sponsor of Sildenafil Cream, 3.6%)

Individual Author Disclosures Presented Below:

  • Sue W. Goldstein

Consultant/Advisory Board: Strategic Science & Technologies, Ipsen;

Research: BTL Industries, Ipsen, Strategic Science & Technologies

  • Tuuli M. Kukkonen

Consultant: Strategic Science & Technologies, LLC

Adrianne Monsef

Employee: Strategic Science & Technologies, LLC

  • Irwin Goldstein

Consultant/Advisory Board: Strategic Science & Technologies, Ipsen;

Research: BTL Industries, Ipsen, Strategic Science & Technologies

Introduction

  • Sildenafil Cream, 3.6%, is a novel topical formulation in Phase 2 clinical development for the treatment of Female Sexual Arousal Disorder (FSAD).
  • Female Sexual Arousal Disorder (FSAD)is characterized by decreased clitoral and labial sensation, reduced genital engorgement and diminished vaginal lubrication.
  • Research to datehas provided substantial evidence supporting the role of the NO-cGMP smooth muscle mediated vasodilatory pathway in the female sexual arousal response, advocating for the continued investigation of Sildenafil Cream, 3.6%, as a first-in-class therapy for FSAD.

Study Objectives

Primary Objective:

  • To evaluate the feasibility of using thermographyto assess the pharmacodynamics of Sildenafil Cream, 3.6% in normal healthy women

Secondary Objectives:

  • To evaluate the preliminary efficacy of 2 grams of Sildenafil Cream, 3.6%on vulvar blood flow, as assessed by thermography in normal healthy women
  • To estimate the time to onset of 2 grams of Sildenafil Cream, 3.6%on vulvar blood flow, as assessed by thermography in normal healthy women
  • To evaluate the preliminary efficacy of 2 grams of 5% Sildenafil Citrateon self-reported physiological genital response, as assessed by the Sexual Arousal Questionnaire
  • To further evaluate the safety of a single-doseof Sildenafil Cream, 3.6%in normal healthy women

Methods

  • Product:Sildenafil Cream, 3.6%
  • Sample:six women (25-55 years) without sexual dysfunction
  • Design: double-blind,placebo-controlled,2-way crossover study
  • Treatment:Visit 1 (no cream); Visits 2-3 (Sildenafil Cream, 3.6% or Placebo Cream)
  • Measurements:temperature in the vestibule and clitoris (by thermography) and self reported arousal (by sexual arousal questionnaire)

Visit 1

Visit 2 and 3

Results: Genital Temperature

Baseline Genital Temperature

Temperature (Celsius)

36

35.5

35

34.5

34

33.5

33

32.5

32

Clitoral Temperature: Pre-Dose

Neutral Film

Temperature (Celsius)

1 2 3 4 5 6 7 8 9 101112131415161718192021222324252627282930

Time (minutes)

Sildenafil Cream, 3.6%

Placebo Cream

Vestibular Temperature: Pre-Dose

Neutral Film

36

35

34

33

32

1 2 3 4 5 6 7 8 9 101112131415161718192021222324252627282930

Time (minutes)

Sildenafil Cream, 3.6%

Placebo Cream

No Significant Differences in Baseline Genital Temperature

(Sildenafil Cream, 3.6% vs. Placebo Cream)

Results: Genital Temperature

Clitoral Temperature and Change During

Sexually Explicit Film

Clitoral Temperature: Sexually

Clitoral Temperature Change: Sexually

Explicit Film

Explicit Film

(Celsius)

36

(Celsius)

3

35.5

2.5

35

34.5

2

Temperature

Temperature Change

34

1.5

33.5

33

1

32.5

0.5

32

1

2

3

4

5

6

7

8

9 101112131415161718192021222324252627282930

0

Time (minutes)

1 2 3 4 5 6 7 8 9 101112131415161718192021222324252627282930

Time (minutes)

Sildenafil Cream, 3.6%

Placebo Cream

Sildenafil Cream, 3.6%

Placebo Cream

Significant Differences in Genital Temperature Over Time

(Sildenafil Cream, 3.6% vs. Placebo Cream) p=.05

Results: Genital Temperature

Vestibular Temperature and Change During

Sexually Explicit Film

Vestibular Temperature: Sexually Explicit Film

Vestibular Temperature Change: Sexually

36

Explicit Film

(Celsius)

35.5

Celsius)

3

34.5

35

2.5

Temperature

34

Change(Temperature

2

1.5

33.5

33

1

32.5

0.5

32

0

1

2

3

4

5

6

7

8

9 101112131415161718192021222324252627282930

1

2

3

4

5

6

7

8

9 101112131415161718192021222324252627282930

Time (minutes)

Time (minutes)

Sildenafil Cream, 3.6%

Placebo Cream

Sildenafil Cream, 3.6%

Placebo Cream

Significant Differences in Genital Temperature Over Time

(Sildenafil Cream, 3.6% vs. Placebo Cream) p=.03

Results: Genital Temperature

Genital Response From One Patient at 30 Minutes

Placebo Cream

Sildenafil Cream

Vestibule: +1.58 ˚C

Vestibule: +2.87 ˚C

Results: Genital Temperature

Linear Slope Analysis During Sexually Explicit Film

Clitoris: Linear Slope During Sexually

Explicit Film

0.25

0.2

Slope

p=.04

0.15

Linear

*

0.1

0.05

0

1 to 5

6 to 10

11 to 15

16 to 20

21 to 25

26 to 30

Time Period (minutes)

Sildenafil Cream 3.6%

Placebo Cream

Linear Slope

Vestibule: Linear Slope During Sexually

Explicit Film

0.25

0.2

p=.02

0.15

0.1

*

0.05

0

1 to 5

6 to 10

11 to 15

16 to 20

21 to 25

26 to 30

Time Period (minutes)

Sildenafil Cream,3.6%

Placebo Cream

Significant difference in linear slope for minutes 11-15

(Sildenafil Cream, 3.6% vs. Placebo Cream)

Results: Self-Reported Arousal

Sexual Arousal Rating

Sildenafil Cream,

Placebo

P value

3.6%

Cream

Overall Sexual Arousal

8.17 (1.17)

7.50

(.55)

.24

Peak Sexual Arousal

8.50 (.84)

7.50

(.55)

.03

Mental Sexual Arousal

8.33 (1.21)

7.00

(1.10)

.07

Feel like having sex with partner

9.17 (.75)

7.50

(1.20)

.02

Feel like masturbating

8.50 (1.38)

7.17

(1.33)

.12

Physical Sexual Arousal

8.33 (1.21)

7.50

(1.05)

.23

Perception of Genital Lubrication

Placebo Cream

Sildenafil Cream, 3.6%

Χ2=6.67 , p=.04

Slightly

Moderately

Not

Very

Extremely

Lubricated

Lubricated

Lubricated

Lubricated

Lubricated

Discussion and Conclusions

  • Sildenafil Cream, 3.6%, when administered to healthy subjects without sexual dysfunction, induced statistically and clinically significant increases in genital and self-reportedmeasures of arousal comparedto placebo cream, exhibiting pharmacodynamic activity 11-15 minutes post-dose.
  • These data support the continued development of Sildenafil Cream, 3.6% to be a promising, on-demand treatment for FSAD patients.
  • Phase 2b multi-centerat-home clinical study planned to be initiated.

ISSWSH 2020, Orlando, FL

Disclaimer

Dare Bioscience Inc. published this content on 09 March 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 March 2020 13:17:10 UTC


© Publicnow 2020
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