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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB-101 | Experimental | Apply to both nipple/areola regions approximately 1 hour prior to sexual activity |
|
| Placebo | Placebo Comparator | Apply to both nipple/areola regions approximately 1 hour prior to sexual activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-101 | Drug | Apply approximately 1 hour prior to sexual activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | [baseline, week 8] |
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Inclusion Criteria:
Exclusion Criteria:
Female Breast Cancer Survivors
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| Name | Affiliation | Role |
|---|---|---|
| Michael Krychman, MD | Southern CA Center for Sexual Health and Survivorship Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern CA Center for Sexual Health and Survivorship Medicine | Newport Beach | California | 92663 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We were unable to recruit a sufficient number of subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo | Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | We were unable to recruit a sufficient number of subjects. | Posted | Mean | Standard Deviation | Grade | [baseline, week 8] |
|
8 weeks
The topical product is used in OTC medications.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andy Goren | Applied Biology, Inc. | (949) 387-4526 | andyg@appliedbiology.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2017 | Jan 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Apply approximately 1 hour prior to sexual activity |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Delayed Orgasm Grade (CTCAE v4.0) | 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 | Mean | Standard Deviation | Grade |
|
| Placebo |
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Placebo | Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009369 |
| Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000588 |
| Amines |