Trial Outcomes & Findings for Clitoral Location in Relation to Sexual Function Using Pelvic Imaging (NCT NCT01195701)

Results Overview

All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.

Recruitment status

COMPLETED

Target enrollment

35 participants

Primary outcome timeframe

Between day 1-14 (follicular phase) of menstrual cycle

Results posted on

2014-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10	25
Overall Study COMPLETED	10	20
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.	Total n=30 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 8.2 • n=5 Participants	31.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	31.6 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
Clitoral Measurements Using Pelvic MRI Glans distance, sagittal, mm	51.3 millimeters (mm) Standard Deviation 7.6	45.1 millimeters (mm) Standard Deviation 5.7
Clitoral Measurements Using Pelvic MRI Body distance, sagittal, mm	29.4 millimeters (mm) Standard Deviation 6.8	20.6 millimeters (mm) Standard Deviation 3.2
Clitoral Measurements Using Pelvic MRI Crura distance, medial axial, mm	24.2 millimeters (mm) Standard Deviation 5.2	28.3 millimeters (mm) Standard Deviation 4.6
Clitoral Measurements Using Pelvic MRI Crura distance, lateral axial, mm	15.6 millimeters (mm) Standard Deviation 6.1	23.8 millimeters (mm) Standard Deviation 3.7
Clitoral Measurements Using Pelvic MRI Total vaginal length, mm	84.5 millimeters (mm) Standard Deviation 11.1	94.9 millimeters (mm) Standard Deviation 6.5
Clitoral Measurements Using Pelvic MRI Clitoris to skin distance, mm	26.6 millimeters (mm) Standard Deviation 11.4	27.0 millimeters (mm) Standard Deviation 6.2
Clitoral Measurements Using Pelvic MRI Midurethra-midvagina distance, mm	13.3 millimeters (mm) Standard Deviation 2.5	12.6 millimeters (mm) Standard Deviation 1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
Free Testosterone	2.6 pg/mL Interval 1.9 to 4.6	2.5 pg/mL Interval 2.2 to 3.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
Total Testosterone	26.5 ng/dL Interval 18.2 to 53.2	33.0 ng/dL Interval 28.6 to 43.9

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
Free Androgen Index	1.3 ratio Interval 0.9 to 2.4	1.2 ratio Interval 1.0 to 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
Female Sexual Function Index (FSFI) Total Score	20.2 units on a scale Standard Deviation 4.4	31.6 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
FSFI Desire	2.6 units on a scale Standard Deviation 1.4	4.8 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
FSFI Arousal	3.2 units on a scale Standard Deviation 0.7	5.4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
FSFI Lubrication	4.0 units on a scale Standard Deviation 1.3	5.5 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
FSFI Orgasm	1.9 units on a scale Standard Deviation 0.7	5.6 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
FSFI Satisfaction	3.6 units on a scale Standard Deviation 1.3	4.8 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anorgasmia (Cases) n=10 Participants Women with difficulty or inability to reach sexual climax will be the cases in this study.	Normal Orgasmic Function n=20 Participants Women who report that they usually or always achieve sexual climax will be the controls in this study.
FSFI Pain	4.9 units on a scale Standard Deviation 1.1	5.5 units on a scale Standard Deviation 0.6

Adverse Events

Anorgasmia (Cases)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Orgasmic Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Academic Clinical Research Supervisor

TriHealth Hatton Research Institute

Phone: 513-862-2330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place