Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

Female Sexual Dysfunction Clinical Trial

Official title:

Clitoral Location in Relation to Sexual Function Using Pelvic MRI: A Case-Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195701
• Other study ID #: 10063
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: November 24, 2014
• Start date: July 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2014
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anorgasmia
• Female Sexual Dysfunction

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
TriHealth Inc.	TriHealth Hatton Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
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	Between day 1-14 (follicular phase) of menstrual cycle	No
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	Between day 1-14 (follicular phase) of menstrual cycle	No
Secondary	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	No
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.	baseline visit	No
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.	baseline visit	No
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.	baseline visit	No
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.	baseline visit	No
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.	baseline visit	No
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.	baseline visit	No
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.	baseline visit	No