Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
Primary Purpose
Sexual Dysfunction, Sexual Arousal Disorder, Sexual Dysfunction, Physiological
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
AB-101
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Dysfunction focused on measuring Nipple Neuropathy, Cancer Survivor
Eligibility Criteria
Inclusion Criteria:
- Female breast cancer survivor
- Age: 18 to 70
- First diagnosed with Stage I or II breast cancer
- Have had breast surgery: nipple sparring mastectomy or lumpectomy
- At least 3 years post surgery
- Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)
- Baseline nipple sensitivity <=5 (likeartLikert scale)
- QoL-BC (>=7)
- Delayed orgasm (CTCAE v4.0) Grade 2
- One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3
- Able to give informed consent
- Currently in a monogamous heterosexual relationship for at least 12 months
- Sexually active within the last 30 days
- Willing to engage in sexual activity at least once a month during the duration of the study
- Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet
- Willing to use an adequate method of birth control
- Able to comply with the study requirements for 8 consecutive weeks
- Able to give informed consent
Exclusion Criteria:
- Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class
- Currently pregnant
- Nursing within the last 6 months prior to beginning the study
- History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery
- Actively being treated for breast cancer
- Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months
- Uncontrolled or severe hypertension
- Decreased oxygen in the tissues or blood
- Active inflammation of the liver
- Acute inflammation of the pancreas
- Overactive thyroid gland
- Acidosis
- Diabetes
- Spinal cord injury
- Nipple dermatitis
- Regional complex pain syndrome
- Use of any hypertensive drugs
- Use of MAO inhibitors
- Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I
- In partners: sexual dysfunction or erectile dysfunction
- Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
- Nipple dermatitis
- Regional complex pain syndrome
- Unable to provide consent or make allotted clinical visits
Sites / Locations
- Southern CA Center for Sexual Health and Survivorship Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AB-101
Placebo
Arm Description
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Outcomes
Primary Outcome Measures
Change in Delayed Orgasm Grade
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03592121
Brief Title
Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
Official Title
Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
October 12, 2019 (Actual)
Study Completion Date
October 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Biology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to investigate the possibility that a topical drug could restore nipple sensitivity and improve sexual quality of life in breast cancer survivors.
Detailed Description
Approximately, 80% of breast cancer survivors undergoing will suffer from a permanent reduced reduction in nipple sensitivity and associated lowerdecrease in sexual quality of life. Currently, there are no treatments for restoring nipple sensitivity and the associatedto improve lower sexual quality of life this condition. It would thus be of great clinical benefit to post breast surgery patients if a provide a new safe and , effective , topical , on-demand, treatment for this condition can be developed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Sexual Arousal Disorder, Sexual Dysfunction, Physiological, Breast Cancer, Nipple Disorder, Neuropathy, Cancer of Breast
Keywords
Nipple Neuropathy, Cancer Survivor
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AB-101
Arm Type
Experimental
Arm Description
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Intervention Type
Drug
Intervention Name(s)
AB-101
Other Intervention Name(s)
Phenylephrine
Intervention Description
Apply approximately 1 hour prior to sexual activity
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle Solution
Intervention Description
Apply approximately 1 hour prior to sexual activity
Primary Outcome Measure Information:
Title
Change in Delayed Orgasm Grade
Description
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
Time Frame
[baseline, week 8]
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female Breast Cancer Survivors
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female breast cancer survivor
Age: 18 to 70
First diagnosed with Stage I or II breast cancer
Have had breast surgery: nipple sparring mastectomy or lumpectomy
At least 3 years post surgery
Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)
Baseline nipple sensitivity <=5 (likeartLikert scale)
QoL-BC (>=7)
Delayed orgasm (CTCAE v4.0) Grade 2
One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3
Able to give informed consent
Currently in a monogamous heterosexual relationship for at least 12 months
Sexually active within the last 30 days
Willing to engage in sexual activity at least once a month during the duration of the study
Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet
Willing to use an adequate method of birth control
Able to comply with the study requirements for 8 consecutive weeks
Able to give informed consent
Exclusion Criteria:
Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class
Currently pregnant
Nursing within the last 6 months prior to beginning the study
History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery
Actively being treated for breast cancer
Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months
Uncontrolled or severe hypertension
Decreased oxygen in the tissues or blood
Active inflammation of the liver
Acute inflammation of the pancreas
Overactive thyroid gland
Acidosis
Diabetes
Spinal cord injury
Nipple dermatitis
Regional complex pain syndrome
Use of any hypertensive drugs
Use of MAO inhibitors
Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I
In partners: sexual dysfunction or erectile dysfunction
Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
Nipple dermatitis
Regional complex pain syndrome
Unable to provide consent or make allotted clinical visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Krychman, MD
Organizational Affiliation
Southern CA Center for Sexual Health and Survivorship Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern CA Center for Sexual Health and Survivorship Medicine
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
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