Clinical trial NCT01195701: Clitoral Location in Relation to Sexual Function Using Pelvic Imaging
Official title: Clitoral Location in Relation to Sexual Function Using Pelvic MRI: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Sexual Dysfunction
Anorgasmia
Keywords: female sexual dysfunction
anorgasmia
clitoral complex
pelvic MRI
testosterone
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
Collaborators: name: TriHealth Hatton Research Institute
First posted: 2010-09-06
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sexually active premenopausal females aged 18-55 years old presenting to private gynecology practice

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clitoral Measurements Using Pelvic MRI
timeFrame: Between day 1-14 (follicular phase) of menstrual cycle
Secondary outcomes:
measure: Free Testosterone
timeFrame: Between day 1-14 (follicular phase) of menstrual cycle
measure: Total Testosterone
timeFrame: Between day 1-14 (follicular phase) of menstrual cycle
measure: Free Androgen Index
timeFrame: Between day 1-14 (follicular phase) of menstrual cycle
measure: Female Sexual Function Index (FSFI) Total Score
timeFrame: baseline visit
measure: FSFI Desire
timeFrame: baseline visit
measure: FSFI Arousal
timeFrame: baseline visit
measure: FSFI Lubrication
timeFrame: baseline visit
measure: FSFI Orgasm
timeFrame: baseline visit
measure: FSFI Satisfaction
timeFrame: baseline visit
measure: FSFI Pain
timeFrame: baseline visit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: Good Samaritan Hospital
name: Christine M Vaccaro, DO
role: PRINCIPAL_INVESTIGATOR
References: