A Phase 2 interventional study of Vaginal Dehydroepiandrosterone and Vaginal Polycarbophil Moisturizer in Vaginal Atrophy, Postmenopausal Symptoms and Breast Cancer Female, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by University of Arkansas · Phase 2, Interventional, and Supportive care
The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone. By doing this study, the investigators hope to learn if Intrarosa® can improve vaginal discomfort. Participants will be assigned to one of two groups. One group will use Intrarosa® once a day. The other group will use Replens™ two times a week.
This will be a two-armed, randomized Phase II trial. All study subjects will be asked to fill out a simple 5-question sexual functioning survey. If any concern about sexual functioning is noted, the subject will also be asked to fill out a more extensive Sexual functioning tool, to help determine which domain of sexual functioning is the most bothersome.
Subjects who complete the initial screening will be randomly assigned to the Intrarosa® or Replens™ arm by a 1:1 ratio. Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks.
At baseline and at 12 weeks, subjects will undergo a physical exam including clinical breast and gynecological exam. During gynecologic exams, the vaginal Potential of Hydrogen (pH) will be determined and a swab of vaginal epithelium sent for determination of the Vaginal Maturation Index (VMI) and Maturation Value (MV). These will be used as objective physiologic markers to determine the improvement in vaginal atrophy. The cytologist's reading specimens will be blinded.
Additionally, all study subjects will be asked to fill out questionnaires at baseline and again in 12 weeks.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vaginal insert with 6.5 mg vaginal DHEA self-administered once daily at bedtime for 12 weeks
Drug: Vaginal Dehydroepiandrosterone
Prefilled vaginal applicator with 2.5 g of polycarbophil vaginal moisturizing gel, self-administered two times per week at night for 12 weeks
Combination Product: Vaginal Polycarbophil Moisturizer
This is a vaginally administered suppository steroid indicated for the treatment of moderate to severe dyspareunia, a frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause.
Also known as: Intrarosa®, Vaginal DHEA, Prasterone
This is an FDA cleared, over-the-counter personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is non-sterile, water-based, non-irritating, non-greasy, non-staining vaginal gel delivered as a long-lasting moisturizer for vaginal dryness.
Also known as: Replens™
Difference in Vaginal Maturation Index (VMI) Response From Baseline to Week 12
The change in the subject's calculated VMI from baseline to the end of treatment at 12 weeks (±1 week). VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is the same as VMI = %S + (0.5 x %I) when simplified. It has a potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \< 50 indicates atrophy.
Time frame: Baseline and 12 weeks (±1 week)
Difference in Vaginal pH From Baseline to Week 12
Vaginal pH was used as an objective physiologic marker to determine the improvement in vaginal atrophy. pH is a measure of acidity and alkalinity and can range from 0 to 14, with 7 being neutral. Lower pH scores are acidic and higher pH scores are basic or alkaline. A normal healthy vaginal pH is 4.5. As the vaginal epithelium becomes thinner and more atrophic, the mucosa has less glycogen content and less lactobacilli to convert the glycogen into lactic acid, which results in an increase in the vaginal pH.
Time frame: 12 weeks (±1 week)
Difference in Dyspareunia Scores on the Brief Sexual Symptom Checklist for Women (BSSC-W) From Baseline to Week 12
The Dyspareunia Score on the BSSC-W asks if there is a problem with pain during sex. A difference score of 0 indicated no change in whether it was a problem. The min and max are both 0 which makes the range also 0. Only 2 participants had week 12 scores. These scores were both 1. (So the min and max were 1 with the range being 0.) Of the baseline scores, these 2 participants both had scores of 1 again. (So the min and max for these 2 participants were both 1 with a range of 0.) If we include these 2 participants with the other 6 who have baseline dyspareunia scores on the BSSC-W, then 7 participants has a score of 1 and 1 participant had a score of 0. This would make the min, max, and range 0, 1, and 1 respectively. As for which value represents a better or worse outcome, 1 indicates presence of dyspareunia while 0 indicates absence of dyspareunia, so 1 is a worse outcome than 0. Subscales are not combined here to produce a total score.
Time frame: 12 weeks (±1 week)
Difference in Vaginal Dryness Scores on the Brief Sexual Symptom Checklist for Women (BSSC-W) From Baseline to Week 12
The min and the max are both 0 which make the range also 0. These were obtained from subtracting each participant's score at baseline from their score at week 12. Only 2 participants had week 12 scores. These scores were both 1. Of the baseline scores, these 2 participants both had scores of 1 again. If 2 participants with the other 6 have baseline dyspareunia scores on the BSSC-W, then 7 participants have a score of 1 and 1 participant had a score of 0. This would make the min, max, and range 0, 1, and 1 respectively. As for which value represents a better or worse outcome, 1 indicates presence of vaginal dryness (problem with decreased vaginal lubrication) while 0 indicates absence of vaginal dryness (or an absence of this problem of decreased vaginal lubrication), so 1 is a worse outcome than 0. Subscales are not combined here to produce a total score.
Time frame: 12 weeks (±1 week)
Difference in Dyspareunia Subscale Scores on the Female Sexual Dysfunction Index (FSFI) From Baseline to Week 12
The Dyspareunia Subscale Score on the Female Sexual Dysfunction Index ranges from 0-5 with higher scores indicating better sexual function, so less dyspareunia.
Time frame: 12 weeks (±1 week)
Difference in Vaginal Dryness Subscale Scores on the Female Sexual Dysfunction Index (FSFI) From Baseline to Week 12
The Vaginal Dryness (or Lubrication) Subscale Score on the Female Sexual Dysfunction Index ranges from 0-5 with higher scores indicating better sexual function, so more lubrication.
Time frame: 12 weeks (±1 week)
Difference in Quality of Life on the Quality of Life - Cancer Survivor Version (QOL-CSV) From Baseline to Week 12
The Quality of Life - Cancer Survivor Version ranges from 0-10 with higher scores indicating a higher quality of life. T here are only 2 difference scores for each of the 4 subscales. The min, max, and ranges of these Well-Being Subscales: Physical -1.00, -0.62, and 0.38. Psychological -0.72, 0.94, and 1.67. Social 0.75, 1.25, and 0.50. Spiritual -1.57, 3.29, and 4.86. For Psychological the min, max, and range are 2.61, 6.83, and 4.22. For Social the min, max, and range are 2.63, 7.38, and 4.75. For Spiritual the min, max, and range are 4.43, 8.43, and 4.00. A negative difference score indicates a worsening of quality of life while a positive score indicates that qualify of life got better. Subscales were not combined here to produce a total score. For the baseline and week 12 scores on the QOL-CSV, higher scores mean higher quality of life.
Time frame: 12 weeks (±1 week)
Potential subjects will be identified in the UAMS CI and UAMS Women's Health clinics and from the CARTI Cancer Center, during routine clinic appointments by the provider or research staff. Potential research subjects may also contact the UAMS Cancer Institute's Clinical Trials Office regarding participation based on the information found within the IRB-approved DHEA flyer that is to be distributed amongst UAMS and the CARTI medical clinics.
| Milestone | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Started | 5 | 3 |
| Completed | 2 | 0 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Ineligible | 0 | 1 |
| Withdrew: Noncompliance | 2 | 1 |
The change in the subject's calculated VMI from baseline to the end of treatment at 12 weeks (±1 week). VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is the same as VMI = %S + (0.5 x %I) when simplified. It has a potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \< 50 indicates atrophy.
| Units on a scale | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Difference in Vaginal Maturation Index (VMI) Response From Baseline to Week 12 | -7.5 ± 24.75 | — |
Vaginal pH was used as an objective physiologic marker to determine the improvement in vaginal atrophy. pH is a measure of acidity and alkalinity and can range from 0 to 14, with 7 being neutral. Lower pH scores are acidic and higher pH scores are basic or alkaline. A normal healthy vaginal pH is 4.5. As the vaginal epithelium becomes thinner and more atrophic, the mucosa has less glycogen content and less lactobacilli to convert the glycogen into lactic acid, which results in an increase in the vaginal pH.
| Units on a scale | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Difference in Vaginal pH From Baseline to Week 12 | -1.00 ± 2.83 | — |
The Dyspareunia Score on the BSSC-W asks if there is a problem with pain during sex. A difference score of 0 indicated no change in whether it was a problem. The min and max are both 0 which makes the range also 0. Only 2 participants had week 12 scores. These scores were both 1. (So the min and max were 1 with the range being 0.) Of the baseline scores, these 2 participants both had scores of 1 again. (So the min and max for these 2 participants were both 1 with a range of 0.) If we include these 2 participants with the other 6 who have baseline dyspareunia scores on the BSSC-W, then 7 participants has a score of 1 and 1 participant had a score of 0. This would make the min, max, and range 0, 1, and 1 respectively. As for which value represents a better or worse outcome, 1 indicates presence of dyspareunia while 0 indicates absence of dyspareunia, so 1 is a worse outcome than 0. Subscales are not combined here to produce a total score.
| Units on a scale | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Difference in Dyspareunia Scores on the Brief Sexual Symptom Checklist for Women (BSSC-W) From Baseline to Week 12 | 0.00 ± 0.00 | — |
The min and the max are both 0 which make the range also 0. These were obtained from subtracting each participant's score at baseline from their score at week 12. Only 2 participants had week 12 scores. These scores were both 1. Of the baseline scores, these 2 participants both had scores of 1 again. If 2 participants with the other 6 have baseline dyspareunia scores on the BSSC-W, then 7 participants have a score of 1 and 1 participant had a score of 0. This would make the min, max, and range 0, 1, and 1 respectively. As for which value represents a better or worse outcome, 1 indicates presence of vaginal dryness (problem with decreased vaginal lubrication) while 0 indicates absence of vaginal dryness (or an absence of this problem of decreased vaginal lubrication), so 1 is a worse outcome than 0. Subscales are not combined here to produce a total score.
| Units on a scale | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Difference in Vaginal Dryness Scores on the Brief Sexual Symptom Checklist for Women (BSSC-W) From Baseline to Week 12 | 0.00 ± 0.00 | — |
The Dyspareunia Subscale Score on the Female Sexual Dysfunction Index ranges from 0-5 with higher scores indicating better sexual function, so less dyspareunia.
| Units on a scale | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Difference in Dyspareunia Subscale Scores on the Female Sexual Dysfunction Index (FSFI) From Baseline to Week 12 | 2.20 ± 3.11 | — |
The Vaginal Dryness (or Lubrication) Subscale Score on the Female Sexual Dysfunction Index ranges from 0-5 with higher scores indicating better sexual function, so more lubrication.
| Units on a scale | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Difference in Vaginal Dryness Subscale Scores on the Female Sexual Dysfunction Index (FSFI) From Baseline to Week 12 | 1.80 ± 2.55 | — |
The Quality of Life - Cancer Survivor Version ranges from 0-10 with higher scores indicating a higher quality of life. T here are only 2 difference scores for each of the 4 subscales. The min, max, and ranges of these Well-Being Subscales: Physical -1.00, -0.62, and 0.38. Psychological -0.72, 0.94, and 1.67. Social 0.75, 1.25, and 0.50. Spiritual -1.57, 3.29, and 4.86. For Psychological the min, max, and range are 2.61, 6.83, and 4.22. For Social the min, max, and range are 2.63, 7.38, and 4.75. For Spiritual the min, max, and range are 4.43, 8.43, and 4.00. A negative difference score indicates a worsening of quality of life while a positive score indicates that qualify of life got better. Subscales were not combined here to produce a total score. For the baseline and week 12 scores on the QOL-CSV, higher scores mean higher quality of life.
| Units on a scale | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| QOL-CSV Physical Well-Being Subscale | -0.81 ± 0.27 | — |
| QOL-CSV Psychological Well-Being Subscale | 0.11 ± 1.18 | — |
| QOL-CSV Social Well-Being Subscale | 1.00 ± 0.35 | — |
| QOL-CSV Spiritual Well-Being Subscale | 0.86 ± 3.43 | — |
Collected over 12 weeks (+/- 1 week). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intrarosa & Standard of Care Aromatase Inhibitor | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Replens & Standard of Care Aromatase Inhibitor | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Event | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor |
|---|---|---|
| Vaginal dischargeReproductive system and breast disorders | 3/5 | 0/3 |
| FatigueGeneral disorders | 2/5 | 0/3 |
| HeadacheNervous system disorders | 2/5 | 0/3 |
| InsomniaPsychiatric disorders | 2/5 | 0/3 |
| Vaginal painReproductive system and breast disorders | 2/5 | 0/3 |
| HypokalemiaMetabolism and nutrition disorders | 0/5 | 1/3 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/5 | 1/3 |
| Upper respiratory infectionInfections and infestations | 0/5 | 1/3 |
| BloatingGastrointestinal disorders | 1/5 | 0/3 |
| Burning with vaginal Intrarosa applicationGeneral disorders | 1/5 | 0/3 |
Postmenopausal females between 18 and 70 with a history of breast cancer.
| Age, Continuous(years) | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor | Total |
|---|---|---|---|
| Mean | 57.8 ± 3.96 | 54.00 ± 15.39 | 56.38 ± 8.98 |
| Sex: Female, Male(Participants) | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 2 | 6 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor | Total |
|---|---|---|---|
| United States | 5 | 3 | 8 |
| Vaginal Maturation Index (VMI)(Units on a scale) | Intrarosa & Standard of Care Aromatase Inhibitor | Replens & Standard of Care Aromatase Inhibitor | Total |
|---|---|---|---|
| Mean | 50.83 ± 16.65 | 36.67 ± 23.23 | 43.75 ± 19.67 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Arkansas