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

NCT03592121 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: RJ-101-RCT-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Sexual Arousal Disorder; Sexual Dysfunction, Physiological; Breast Cancer; Nipple Disorder; Neuropathy; Cancer of Breast

Keywords

Nipple Neuropathy, Cancer Survivor

Outcome Measures

Primary Outcomes (1)

• 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]

Study Arms (2)

AB-101

EXPERIMENTAL

Apply to both nipple/areola regions approximately 1 hour prior to sexual activity

Drug: AB-101

Placebo

PLACEBO COMPARATOR

Apply to both nipple/areola regions approximately 1 hour prior to sexual activity

Drug: Placebo

Interventions

AB-101 DRUG

Apply approximately 1 hour prior to sexual activity

Also known as: Phenylephrine

AB-101

Placebo DRUG

Apply approximately 1 hour prior to sexual activity

Also known as: Vehicle Solution

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female Breast Cancer Survivors
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (1)

Southern CA Center for Sexual Health and Survivorship Medicine

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Breast Neoplasms

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. Andy Goren
• Organization: Applied Biology, Inc.

andyg@appliedbiology.com

(949) 387-4526

Study Officials

• Michael Krychman, MD

  Southern CA Center for Sexual Health and Survivorship Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: July 19, 2018
• Study Start: July 9, 2018
• Primary Completion: October 12, 2019
• Study Completion: October 12, 2019
• Last Updated: March 12, 2020
• Results First Posted: March 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)