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Low recruitment/enrollment
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| Name | Class |
|---|---|
| AMAG Pharmaceuticals, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal DHEA | Experimental | Vaginal insert with 6.5 mg vaginal DHEA self-administered once daily at bedtime for 12 weeks |
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| Vaginal Polycarbophil Moisturizer | Active Comparator | Prefilled vaginal applicator with 2.5 g of polycarbophil vaginal moisturizing gel, self-administered two times per week at night for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Dehydroepiandrosterone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks (±1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Richard-Davis, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Females of childbearing age and potential must have negative pregnancy test at screening. Any consented individuals who do not indicate sexual complaints on Question 1 of the BSSC-W at baseline will be considered a screen fail and will not complete the FSFI or continue in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrarosa & Standard of Care Aromatase Inhibitor | Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). |
| FG001 | Replens & Standard of Care Aromatase Inhibitor |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2023 |
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Subjects are 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.
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The cytologist's reading specimens will be blinded.
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| Vaginal Polycarbophil Moisturizer | Combination Product | 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. |
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| 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. | 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. | 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. | 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. | 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. | 12 weeks (±1 week) |
Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
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| NOT COMPLETED |
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Postmenopausal females between 18 and 70 with a history of breast cancer.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrarosa & Standard of Care Aromatase Inhibitor | Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). |
| BG001 | Replens & Standard of Care Aromatase Inhibitor | Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Vaginal Maturation Index (VMI) | VMI is a clinical measure of vaginal estrogenization, indicator of the degree of vaginal atrophy which is the end result of treatment with aromatase inhibitors that leads to vaginal dryness and dyspareunia. VMI is the proportional relationship of parabasal (P) cells to intermediate (I) and superficial (S) cells in the vaginal epithelium. VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is VMI=%S + (0.5 x %I) when simplified, 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. | Mean | Standard Deviation | Units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Out of 8 participants assigned to a treatment arm, only 2 had VMI measured at both the baseline and 12-week visits. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 12 weeks (±1 week) |
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| Secondary | 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. | Out of 8 participants assigned to a treatment arm, only 2 had vaginal pH measured at both the baseline and 12-week visits. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (±1 week) |
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| Secondary | 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. | Out of 8 participants assigned to a treatment arm, only 2 took the BSSC-W at both the baseline and 12-week visits. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (±1 week) |
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| Secondary | 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. | Out of 8 participants assigned to a treatment arm, only 2 took the BSSC-W at both the baseline and 12-week visits. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (±1 week) |
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| Secondary | 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. | Out of 8 participants assigned to a treatment arm, only 2 took the FSFI at both the baseline and 12-week visits. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (±1 week) |
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| Secondary | 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. | Out of 8 participants assigned to a treatment arm, only 2 took the FSFI at both the baseline and 12-week visits. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (±1 week) |
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| Secondary | 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. | Out of 8 participants assigned to a treatment arm, only 2 took the QOL-CSV at both the baseline and 12-week visits. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (±1 week) |
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12 weeks (+/- 1 week)
AEs are to be reported in a routine fashion at scheduled times during the trial. Certain AEs must be reported in an expedited fashion to allow for timely monitoring of subject safety and care.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrarosa & Standard of Care Aromatase Inhibitor | Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). | 0 | 5 | 0 | 5 | 4 | 5 |
| EG001 | Replens & Standard of Care Aromatase Inhibitor | Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week). | 0 | 3 | 0 | 3 | 1 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Burning with vaginal Intrarosa application | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Dyspareunia | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Herpes simplex reactivation | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Hirsutism | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Irritability | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Other, specify: Vaginal pulsing sensation | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Other, specify: Vulva swelling | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Other: Vaginal fullness | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Vaginal dryness | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Vaginal infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Vaginal pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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Early termination due to low enrollment and lack of subject participation/noncompliance.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| I-Shin Wen | University of Arkansas for Medical Sciences | 5016868274 | 24024 | iwen@uams.edu |
| Jul 12, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| C085472 | Replens |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
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