Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03592121 |
Recruitment Status :
Completed
First Posted : July 19, 2018
Results First Posted : March 12, 2020
Last Update Posted : March 12, 2020
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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 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 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 |
Actual Primary Completion Date : | October 12, 2019 |
Actual Study Completion Date : | October 12, 2019 |

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 |
- Change in Delayed Orgasm Grade [ Time Frame: [baseline, week 8] ]
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

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 |
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

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
United States, California | |
Southern CA Center for Sexual Health and Survivorship Medicine | |
Newport Beach, California, United States, 92663 |
Principal Investigator: | Michael Krychman, MD | Southern CA Center for Sexual Health and Survivorship Medicine |
Documents provided by Applied Biology, Inc.:
Responsible Party: | Applied Biology, Inc. |
ClinicalTrials.gov Identifier: | NCT03592121 |
Other Study ID Numbers: |
RJ-101-RCT-001 |
First Posted: | July 19, 2018 Key Record Dates |
Results First Posted: | March 12, 2020 |
Last Update Posted: | March 12, 2020 |
Last Verified: | February 2020 |
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 |
Nipple Neuropathy, Cancer Survivor |
Breast Neoplasms Sexual Dysfunction, Physiological Disease Sexual Dysfunctions, Psychological Pathologic Processes Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Mental Disorders 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 |