Anorgasmia, Female Sexual Dysfunction
Conditions
Keywords
female sexual dysfunction, anorgasmia, clitoral complex, pelvic MRI, testosterone
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
TriHealth Hatton Research Institute
TriHealth Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Premenopausal female aged 18-55 years * Sexually active (at least 1 heterosexual partner in the past 4 weeks) * Cases must have difficulty with orgasm or be anorgasmic * Controls must have normal sexual function
Exclusion criteria
* Not sexually active * Homosexual orientation * Postmenopausal * Stage \>2 pelvic organ prolapse (POP-Q measurements beyond hymen) * Urinary incontinence with coitus limiting sexual activity * Severe vaginal atrophy * Pelvic pain/dyspareunia ( * Currently pregnant * Depression being treated with SSRIs (depression alone or treatment of depression with non-SSRI medications is not an exclusion) * Currently taking testosterone supplements * History of sexual abuse * Large pelvic mass (benign or cancerous) impeding MRI measurements or grossly abnormal pelvic anatomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clitoral Measurements Using Pelvic MRI | Between day 1-14 (follicular phase) of menstrual cycle | All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Testosterone | Between day 1-14 (follicular phase) of menstrual cycle | 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 |
| Free Androgen Index | Between day 1-14 (follicular phase) of menstrual cycle | Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG) |
| Female Sexual Function Index (FSFI) Total Score | baseline visit | 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. |
| FSFI Desire | baseline visit | 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. |
| Free Testosterone | Between day 1-14 (follicular phase) of menstrual cycle | Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements |
| FSFI Lubrication | baseline visit | 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. |
| FSFI Orgasm | baseline visit | 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. |
| FSFI Satisfaction | baseline visit | 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. |
| FSFI Pain | baseline visit | 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. |
| FSFI Arousal | baseline visit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anorgasmia (Cases) Women with difficulty or inability to reach sexual climax will be the cases in this study. | 10 |
| Normal Orgasmic Function Women who report that they usually or always achieve sexual climax will be the controls in this study. | 20 |
| Total | 30 |
Baseline characteristics
| Characteristic | Normal Orgasmic Function | Total | Anorgasmia (Cases) |
|---|---|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 7.2 | 31.6 years STANDARD_DEVIATION 7.4 | 31.7 years STANDARD_DEVIATION 8.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 27 Participants | 8 Participants |
| Sex: Female, Male Female | 20 Participants | 30 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 20 |
| serious Total, serious adverse events | 0 / 10 | 0 / 20 |
Outcome results
Primary
Clitoral Measurements Using Pelvic MRI
All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.
Time frame: Between day 1-14 (follicular phase) of menstrual cycle
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anorgasmia (Cases) | Clitoral Measurements Using Pelvic MRI | Body distance, sagittal, mm | 29.4 millimeters (mm) | Standard Deviation 6.8 |
| Anorgasmia (Cases) | Clitoral Measurements Using Pelvic MRI | Crura distance, lateral axial, mm | 15.6 millimeters (mm) | Standard Deviation 6.1 |
| Anorgasmia (Cases) | Clitoral Measurements Using Pelvic MRI | Glans distance, sagittal, mm | 51.3 millimeters (mm) | Standard Deviation 7.6 |
| Anorgasmia (Cases) | Clitoral Measurements Using Pelvic MRI | Total vaginal length, mm | 84.5 millimeters (mm) | Standard Deviation 11.1 |
| Anorgasmia (Cases) | Clitoral Measurements Using Pelvic MRI | Crura distance, medial axial, mm | 24.2 millimeters (mm) | Standard Deviation 5.2 |
| Anorgasmia (Cases) | Clitoral Measurements Using Pelvic MRI | Clitoris to skin distance, mm | 26.6 millimeters (mm) | Standard Deviation 11.4 |
| Anorgasmia (Cases) | Clitoral Measurements Using Pelvic MRI | Midurethra-midvagina distance, mm | 13.3 millimeters (mm) | Standard Deviation 2.5 |
| Normal Orgasmic Function | Clitoral Measurements Using Pelvic MRI | Clitoris to skin distance, mm | 27.0 millimeters (mm) | Standard Deviation 6.2 |
| Normal Orgasmic Function | Clitoral Measurements Using Pelvic MRI | Midurethra-midvagina distance, mm | 12.6 millimeters (mm) | Standard Deviation 1 |
| Normal Orgasmic Function | Clitoral Measurements Using Pelvic MRI | Glans distance, sagittal, mm | 45.1 millimeters (mm) | Standard Deviation 5.7 |
| Normal Orgasmic Function | Clitoral Measurements Using Pelvic MRI | Body distance, sagittal, mm | 20.6 millimeters (mm) | Standard Deviation 3.2 |
| Normal Orgasmic Function | Clitoral Measurements Using Pelvic MRI | Crura distance, medial axial, mm | 28.3 millimeters (mm) | Standard Deviation 4.6 |
| Normal Orgasmic Function | Clitoral Measurements Using Pelvic MRI | Crura distance, lateral axial, mm | 23.8 millimeters (mm) | Standard Deviation 3.7 |
| Normal Orgasmic Function | Clitoral Measurements Using Pelvic MRI | Total vaginal length, mm | 94.9 millimeters (mm) | Standard Deviation 6.5 |
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.
Time frame: baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anorgasmia (Cases) | Female Sexual Function Index (FSFI) Total Score | 20.2 units on a scale | Standard Deviation 4.4 |
| Normal Orgasmic Function | Female Sexual Function Index (FSFI) Total Score | 31.6 units on a scale | Standard Deviation 2.7 |
Secondary
Free Androgen Index
Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)
Time frame: Between day 1-14 (follicular phase) of menstrual cycle
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anorgasmia (Cases) | Free Androgen Index | 1.3 ratio |
| Normal Orgasmic Function | Free Androgen Index | 1.2 ratio |
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
Time frame: Between day 1-14 (follicular phase) of menstrual cycle
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anorgasmia (Cases) | Free Testosterone | 2.6 pg/mL |
| Normal Orgasmic Function | Free Testosterone | 2.5 pg/mL |
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.
Time frame: baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anorgasmia (Cases) | FSFI Arousal | 3.2 units on a scale | Standard Deviation 0.7 |
| Normal Orgasmic Function | FSFI Arousal | 5.4 units on a scale | Standard Deviation 0.6 |
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.
Time frame: baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anorgasmia (Cases) | FSFI Desire | 2.6 units on a scale | Standard Deviation 1.4 |
| Normal Orgasmic Function | FSFI Desire | 4.8 units on a scale | Standard Deviation 0.7 |
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.
Time frame: baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anorgasmia (Cases) | FSFI Lubrication | 4.0 units on a scale | Standard Deviation 1.3 |
| Normal Orgasmic Function | FSFI Lubrication | 5.5 units on a scale | Standard Deviation 0.5 |
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.
Time frame: baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anorgasmia (Cases) | FSFI Orgasm | 1.9 units on a scale | Standard Deviation 0.7 |
| Normal Orgasmic Function | FSFI Orgasm | 5.6 units on a scale | Standard Deviation 0.6 |
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.
Time frame: baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anorgasmia (Cases) | FSFI Pain | 4.9 units on a scale | Standard Deviation 1.1 |
| Normal Orgasmic Function | FSFI Pain | 5.5 units on a scale | Standard Deviation 0.6 |
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.
Time frame: baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anorgasmia (Cases) | FSFI Satisfaction | 3.6 units on a scale | Standard Deviation 1.3 |
| Normal Orgasmic Function | FSFI Satisfaction | 4.8 units on a scale | Standard Deviation 0.8 |
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
Time frame: Between day 1-14 (follicular phase) of menstrual cycle
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anorgasmia (Cases) | Total Testosterone | 26.5 ng/dL |
| Normal Orgasmic Function | Total Testosterone | 33.0 ng/dL |