Trial Outcomes & Findings for Study to Investigate the Effect of AB-101 in Breast Cancer Survivors (NCT NCT03592121)

Last Updated: 2020-03-12

Results Overview

Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0 Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax. This is a binary grading system: Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

3 participants

Primary outcome timeframe

[baseline, week 8]

Results posted on

2020-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	AB-101 Apply to both nipple/areola regions approximately 1 hour prior to sexual activity AB-101: Apply approximately 1 hour prior to sexual activity	Placebo Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity
Overall Study STARTED	3	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Investigate the Effect of AB-101 in Breast Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AB-101 n=3 Participants Apply to both nipple/areola regions approximately 1 hour prior to sexual activity AB-101: Apply approximately 1 hour prior to sexual activity	Placebo Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants
Delayed Orgasm Grade (CTCAE v4.0)	0.67 Grade STANDARD_DEVIATION 0.58 • n=5 Participants	—	0.67 Grade STANDARD_DEVIATION 0.58 • n=5 Participants

PRIMARY outcome

Timeframe: [baseline, week 8]

Population: We were unable to recruit a sufficient number of subjects.

Outcome measures

Outcome measures
Measure	AB-101 n=3 Participants Apply to both nipple/areola regions approximately 1 hour prior to sexual activity AB-101: Apply approximately 1 hour prior to sexual activity	Placebo Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity
Change in Delayed Orgasm Grade	-0.33 Grade Standard Deviation 0.58	—

Adverse Events

AB-101

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andy Goren

Applied Biology, Inc.

Phone: (949) 387-4526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place