An Early Phase 1 interventional study of AB-101 and Placebo in Sexual Dysfunction, Sexual Arousal Disorder and Sexual Dysfunction, Physiological, sponsored by Applied Biology, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Applied Biology, Inc. · Early Phase 1, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 3 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Applied Biology, Inc. is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Drug: AB-101
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Drug: Placebo
Apply approximately 1 hour prior to sexual activity
Also known as: Phenylephrine
Apply approximately 1 hour prior to sexual activity
Also known as: Vehicle Solution
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
Time frame: [baseline, week 8]
| Milestone | AB-101 | Placebo |
|---|---|---|
| Started | 3 | 0 |
| Completed | 3 | 0 |
| Not completed | 0 | 0 |
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
| Grade | AB-101 | Placebo |
|---|---|---|
| Change in Delayed Orgasm Grade | -0.33 ± 0.58 | — |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AB-101 | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Placebo | — | — | — |
We were unable to recruit a sufficient number of subjects.
| Age, Categorical(Participants) | AB-101 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 0 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | AB-101 | Placebo | Total |
|---|---|---|---|
| Female | 3 | 0 | 3 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | AB-101 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 3 | — | 3 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | AB-101 | Placebo | Total |
|---|---|---|---|
| United States | 3 | — | 3 |
| Delayed Orgasm Grade (CTCAE v4.0)(Grade) | AB-101 | Placebo | Total |
|---|---|---|---|
| Mean | 0.67 ± 0.58 | — | 0.67 ± 0.58 |
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Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Applied Biology, Inc.