Trial record 1 of 1 for: NCT03592121

Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03592121

Recruitment Status : Recruiting

First Posted : July 19, 2018

Last Update Posted : October 5, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Applied Biology, Inc.

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.

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


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, 2019
Estimated Study Completion Date :	November 12, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Cancer--Living with Cancer

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


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:	October 5, 2018
Last Verified:	October 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

To Top