Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

This study has been completed.
Sponsor:
Collaborator:
TriHealth Hatton Research Institute
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01195701
First received: September 3, 2010
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

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.


Condition
Female Sexual Dysfunction
Anorgasmia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clitoral Location in Relation to Sexual Function Using Pelvic MRI: A Case-Control Study

Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Clitoral Measurements Using Pelvic MRI [ Time Frame: Between day 1-14 (follicular phase) of menstrual cycle ] [ Designated as safety issue: No ]
    All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.


Secondary Outcome Measures:
  • Free Testosterone [ Time Frame: Between day 1-14 (follicular phase) of menstrual cycle ] [ Designated as safety issue: No ]
    Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements

  • Total Testosterone [ Time Frame: Between day 1-14 (follicular phase) of menstrual cycle ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between day 1-14 (follicular phase) of menstrual cycle ] [ Designated as safety issue: No ]
    Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)

  • Female Sexual Function Index (FSFI) Total Score [ Time Frame: baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline visit ] [ Designated as safety issue: No ]
    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.

  • FSFI Arousal [ Time Frame: baseline visit ] [ Designated as safety issue: No ]
    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.

  • FSFI Lubrication [ Time Frame: baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline visit ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood hormone levels


Enrollment: 35
Study Start Date: July 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Sexually active premenopausal females aged 18-55 years old presenting to private gynecology practice

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195701

Locations
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
TriHealth Hatton Research Institute
Investigators
Principal Investigator: Christine M Vaccaro, DO Good Samaritan Hospital
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01195701     History of Changes
Other Study ID Numbers: 10063
Study First Received: September 3, 2010
Results First Received: April 29, 2014
Last Updated: November 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
female sexual dysfunction
anorgasmia
clitoral complex
pelvic MRI
testosterone

ClinicalTrials.gov processed this record on September 03, 2015