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

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ClinicalTrials.gov Identifier: NCT03592121
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Sexual Arousal Disorder Sexual Dysfunction, Physiological Breast Cancer Nipple Disorder Neuropathy Cancer of Breast Drug: AB-101 Drug: Placebo Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : November 12, 2018
Estimated Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AB-101
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
 Drug: AB-101
Apply approximately 1 hour prior to sexual activity
Other Name: Phenylephrine
Placebo Comparator: Placebo
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
 Drug: Placebo
Apply approximately 1 hour prior to sexual activity
Other Name: Vehicle Solution


Outcome Measures
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Primary Outcome Measures :
  1. Delayed Orgasm [ Time Frame: [baseline, week 4, week 8] ]
    Change in Delayed Orgasm (CTCAE v4.0)

  2. Vaginal Dryness [ Time Frame: [baseline, week 4, week 8] ]
    Change in Vaginal Dryness (CTCAE v4.0)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female Breast Cancer Survivors
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592121


Contacts
Contact: Monica Naegle 949-387-4526‬ monican@appliedbiology.com

Locations
United States, California
Southern CA Center for Sexual Health and Survivorship Medicine Recruiting
Newport Beach, California, United States, 92663
Contact: Michael Kyrchman    949-764-9300    MKRYCHMAN@icloud.com   
Principal Investigator: Michael Kyrchman, MD         
Sponsors and Collaborators
Applied Biology, Inc.
Investigators
Principal Investigator: Michael Krychman, MD Southern CA Center for Sexual Health and Survivorship Medicine
More Information
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Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT03592121     History of Changes
Other Study ID Numbers: RJ-101-RCT-001
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Applied Biology, Inc.:
Nipple Neuropathy, Cancer Survivor

Additional relevant MeSH terms:
Disease
Breast Neoplasms
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female
Phenylephrine
Cardiotonic Agents
Mydriatics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents