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Completed

NCT Number: NCT01195701

Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

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.

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Key information

Conditions

Female Sexual Dysfunction Anorgasmia

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Clitoral Measurements Using Pelvic MRI

    Time frame: 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 outcomes

  1. Free Testosterone

    Time frame: 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

  2. Total Testosterone

    Time frame: 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

  3. Free Androgen Index

    Time frame: 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)

  4. Female Sexual Function Index (FSFI) Total Score

    Time frame: 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.

  5. FSFI Desire

    Time frame: 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.

  6. FSFI Arousal

    Time frame: 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.

  7. FSFI Lubrication

    Time frame: 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.

  8. FSFI Orgasm

    Time frame: 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.

  9. FSFI Satisfaction

    Time frame: 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.

  10. FSFI Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Collaborators

  • TriHealth Hatton Research Institute

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 6, 2010
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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