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

NCT ID: NCT03592121

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2019-10-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AB-101

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

Group Type: EXPERIMENTAL

AB-101

Intervention Type: DRUG

Apply approximately 1 hour prior to sexual activity

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Apply approximately 1 hour prior to sexual activity

Interventions

AB-101

Apply approximately 1 hour prior to sexual activity

Intervention Type: DRUG

Placebo

Apply approximately 1 hour prior to sexual activity

Intervention Type: DRUG

Other Intervention Names

Phenylephrine; Vehicle Solution

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Applied Biology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Krychman, MD

Role: PRINCIPAL_INVESTIGATOR

Southern CA Center for Sexual Health and Survivorship Medicine

Locations

Southern CA Center for Sexual Health and Survivorship Medicine

Newport Beach, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RJ-101-RCT-001

Identifier Type: -

Identifier Source: org_study_id