Sexual DysfunctionEarly Phase 1NCT03592121
Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
A Early Phase 1 study testing AB-101 in people with Sexual Dysfunction and Sexual Arousal Disorder, run by Applied Biology, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Sexual Arousal Disorder, Sexual Dysfunction, Physiological
- What is being tested?
- AB-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 12 Oct 2019
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern CA Center for Sexual Health and Survivorship Medicine
Newport Beach, California, 92663
About this study
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.
Read the 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
- Being tested
- AB-101, Placebo
- Keywords
- Nipple Neuropathy, Cancer Survivor
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-101Drug
Also called Phenylephrine
Apply approximately 1 hour prior to sexual activity
PlaceboDrug
Also called Vehicle Solution
Apply approximately 1 hour prior to sexual activity
| Study group | Role | What they receive |
|---|---|---|
| AB-101 | Experimental | Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Receives: Drug: AB-101 |
| Placebo | Placebo comparator | Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [baseline, week 8]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start9 Jul 2018
- Primary completion12 Oct 2019
- Study completion12 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Krychman, MD, Principal investigator, Southern CA Center for Sexual Health and Survivorship Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592121
- Sponsor's protocol ID
- RJ-101-RCT-001
- Status last verified
- Feb 2020
- First submitted
- 8 Jul 2018
- Last updated
- 12 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03592121
- Acronym / sponsor ID
- RJ-101-RCT-001
- Conditions
- Sexual Dysfunction, Sexual Arousal Disorder, Sexual Dysfunction, Physiological, Breast Cancer, Nipple Disorder, Neuropathy
- Keywords
- Nipple Neuropathy, Cancer Survivor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 12 Oct 2019 (actual)
- Study completion
- 12 Oct 2019 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Posted 12 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB-101 | Experimental | Drug: AB-101Apply to both nipple/areola regions approximately 1 hour prior to sexual activity |
| Placebo | Placebo comparator | Drug: PlaceboApply to both nipple/areola regions approximately 1 hour prior to sexual activity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-101Also: PhenylephrineApply approximately 1 hour prior to sexual activity | Drug | AB-101 |
| PlaceboAlso: Vehicle SolutionApply approximately 1 hour prior to sexual activity | Drug | Placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Krychman, MD principal investigator
Southern CA Center for Sexual Health and Survivorship Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AB-101 in people with Sexual Dysfunction and Sexual Arousal Disorder, run by Applied Biology, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Delayed Orgasm Grade (time frame: [baseline, week 8]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.