Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

NCT01195701 | Completed Results

• 1 other identifier: 10063
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Dysfunction; Anorgasmia

Keywords

female sexual dysfunction; anorgasmia; clitoral complex; pelvic MRI; testosterone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Free Testosterone

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

• Total Testosterone

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

• Free Androgen Index

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

• Female Sexual Function Index (FSFI) Total Score

  baseline visit

• FSFI Desire

  baseline visit

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Currently taking testosterone supplements
• History of sexual abuse
• Large pelvic mass (benign or cancerous) impeding MRI measurements or grossly abnormal pelvic anatomy.

Sponsors & Collaborators

• TriHealth Inc.: lead
• TriHealth Hatton Research Institute: collaborator

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood hormone levels

Results Point of Contact

• Title: Academic Clinical Research Supervisor
• Organization: TriHealth Hatton Research Institute

Angie_Fellner@trihealth.com

513-862-2330

Study Officials

• Christine M Vaccaro, DO

  Good Samaritan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 3, 2014
• Results First Posted: December 3, 2014

Record last verified: 2014-11

Locations

US (1)