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| Name | Class |
|---|---|
| TriHealth Hatton Research Institute | OTHER |
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Women who are unable to achieve orgasm compared to women who have normal orgasmic function may have different clitoral anatomy and different hormone levels. The investigators hypothesis is that women who have difficulty with orgasm may have a clitoris that is closer to the vagina and may have higher testosterone levels. Pelvic MRI will be used to observe whether clitoral measurements differ between women with normal orgasmic function vs. those with anorgasmia.
Women unable with anorgasmia and those with normal orgasmic function will undergo pelvic MRI so that clitoral measurements can be taken and then compared for differences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anorgasmia (cases) | Women with difficulty or inability to reach sexual climax will be the cases in this study. | ||
| Normal orgasmic function | Women who report that they usually or always achieve sexual climax will be the controls in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clitoral Measurements Using Pelvic MRI | All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex. | Between day 1-14 (follicular phase) of menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Free Testosterone | Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements | Between day 1-14 (follicular phase) of menstrual cycle |
| Total Testosterone |
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Inclusion Criteria:
Exclusion Criteria:
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Sexually active premenopausal females aged 18-55 years old presenting to private gynecology practice
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| Name | Affiliation | Role |
|---|---|---|
| Christine M Vaccaro, DO | Good Samaritan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anorgasmia (Cases) | Women with difficulty or inability to reach sexual climax will be the cases in this study. |
| FG001 | Normal Orgasmic Function | Women who report that they usually or always achieve sexual climax will be the controls in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A sample size calculation determined that with an alpha level of 0.05 a sample size of 13 participants in each arm (N=26) would yield 90% power to detect a mean difference of 5.6 between groups on the FSFI Orgasm subscale. We planned to enroll 40 patients (20 in each arm) to accommodate a predicted dropout rate of approximately 40%.
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| ID | Title | Description |
|---|---|---|
| BG000 | Anorgasmia (Cases) | Women with difficulty or inability to reach sexual climax will be the cases in this study. |
| BG001 | Normal Orgasmic Function | Women who report that they usually or always achieve sexual climax will be the controls in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Clitoral Measurements Using Pelvic MRI | All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex. | Posted | Mean | Standard Deviation | millimeters (mm) | Between day 1-14 (follicular phase) of menstrual cycle |
|
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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 | Anorgasmia (Cases) | Women with difficulty or inability to reach sexual climax will be the cases in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Academic Clinical Research Supervisor | TriHealth Hatton Research Institute | 513-862-2330 | Angie_Fellner@trihealth.com |
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Blood hormone levels
Free & total testosterone, and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements |
| Between day 1-14 (follicular phase) of menstrual cycle |
| Free Androgen Index | Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG) | Between day 1-14 (follicular phase) of menstrual cycle |
| Female Sexual Function Index (FSFI) Total Score | The FSFI is a validated index of sexual function, consisting of a total score and six subscales or domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total is the sum of the six domain scores, each of which is weighted as noted. The FSFI total score can range from 2 to 36, with higher scores indicating better sexual function. A total score of 26.55 has been identified as the ideal cut point for differentiating between normal sexual function and sexual dysfunction. | baseline visit |
| FSFI Desire | The desire domain of the Female Sexual Function Index (FSFI) consists of two questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual desire. Item scores range from 1 to 5, with higher scores indicating better sexual function, and the domain score is weighted by a factor of 0.6, such that the domain score can range from 1.2 to 6.0. | baseline visit |
| FSFI Arousal | The arousal domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual arousal; and confidence in becoming aroused (very low to very high confidence) and frequency of satisfaction with arousal (almost never to almost always). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the arousal score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0. | baseline visit |
| FSFI Lubrication | The lubrication domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency of lubrication (almost never to almost always), the difficulty in becoming lubricated (extremely difficult to not difficult), frequency of maintaining lubrication (almost never to almost always), and difficulty in maintaining lubrication (extremely difficult to not difficult). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the lubrication score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0. | baseline visit |
| FSFI Orgasm | The orgasm domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of orgasm (almost never to almost always), difficulty in achieving orgasm (extremely difficult to not difficult), and satisfaction with the ability to reach orgasm (very dissatisfied to very satisfied). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the orgasm score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0. | baseline visit |
| FSFI Satisfaction | The satisfaction domain of the Female Sexual Function Index (FSFI) consists of three questions and measures satisfaction (very dissatisfied to very satisfied) with emotional closeness with partner, sexual relationship with partner, and overall sexual relationship with partner. Item scores range from 0 (or 1) to 5, with higher scores indicating better sexual function, and the satisfaction score is weighted by a factor of 0.4, such that the domain score can range from 0.8 to 6.0. | baseline visit |
| FSFI Pain | The pain domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of discomfort or pain during and following vaginal penetration (almost never to almost always), and the level of discomfort or pain (very low to very high). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the pain score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0. | baseline visit |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Free Testosterone | Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements | Posted | Median | Inter-Quartile Range | pg/mL | Between day 1-14 (follicular phase) of menstrual cycle |
|
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| Secondary | Total Testosterone | Free & total testosterone, and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements | Posted | Median | Inter-Quartile Range | ng/dL | Between day 1-14 (follicular phase) of menstrual cycle |
|
|
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| Secondary | Free Androgen Index | Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG) | Posted | Number | 95% Confidence Interval | ratio | Between day 1-14 (follicular phase) of menstrual cycle |
|
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| Secondary | Female Sexual Function Index (FSFI) Total Score | The FSFI is a validated index of sexual function, consisting of a total score and six subscales or domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total is the sum of the six domain scores, each of which is weighted as noted. The FSFI total score can range from 2 to 36, with higher scores indicating better sexual function. A total score of 26.55 has been identified as the ideal cut point for differentiating between normal sexual function and sexual dysfunction. | Posted | Mean | Standard Deviation | units on a scale | baseline visit |
|
|
|
| Secondary | FSFI Desire | The desire domain of the Female Sexual Function Index (FSFI) consists of two questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual desire. Item scores range from 1 to 5, with higher scores indicating better sexual function, and the domain score is weighted by a factor of 0.6, such that the domain score can range from 1.2 to 6.0. | Posted | Mean | Standard Deviation | units on a scale | baseline visit |
|
|
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| Secondary | FSFI Arousal | The arousal domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual arousal; and confidence in becoming aroused (very low to very high confidence) and frequency of satisfaction with arousal (almost never to almost always). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the arousal score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0. | Posted | Mean | Standard Deviation | units on a scale | baseline visit |
|
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|
| Secondary | FSFI Lubrication | The lubrication domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency of lubrication (almost never to almost always), the difficulty in becoming lubricated (extremely difficult to not difficult), frequency of maintaining lubrication (almost never to almost always), and difficulty in maintaining lubrication (extremely difficult to not difficult). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the lubrication score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0. | Posted | Mean | Standard Deviation | units on a scale | baseline visit |
|
|
|
| Secondary | FSFI Orgasm | The orgasm domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of orgasm (almost never to almost always), difficulty in achieving orgasm (extremely difficult to not difficult), and satisfaction with the ability to reach orgasm (very dissatisfied to very satisfied). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the orgasm score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0. | Posted | Mean | Standard Deviation | units on a scale | baseline visit |
|
|
|
| Secondary | FSFI Satisfaction | The satisfaction domain of the Female Sexual Function Index (FSFI) consists of three questions and measures satisfaction (very dissatisfied to very satisfied) with emotional closeness with partner, sexual relationship with partner, and overall sexual relationship with partner. Item scores range from 0 (or 1) to 5, with higher scores indicating better sexual function, and the satisfaction score is weighted by a factor of 0.4, such that the domain score can range from 0.8 to 6.0. | Posted | Mean | Standard Deviation | units on a scale | baseline visit |
|
|
|
| Secondary | FSFI Pain | The pain domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of discomfort or pain during and following vaginal penetration (almost never to almost always), and the level of discomfort or pain (very low to very high). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the pain score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0. | Posted | Mean | Standard Deviation | units on a scale | baseline visit |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Normal Orgasmic Function | Women who report that they usually or always achieve sexual climax will be the controls in this study. | 0 | 20 | 0 | 20 |
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