Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by TriHealth Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hatton Institute for Research and Education
Information provided by:
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01195701
First received: September 3, 2010
Last updated: July 20, 2011
Last verified: September 2010
  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.


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 by pelvic MRI [ Time Frame: one year ] [ Designated as safety issue: No ]
    All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.


Secondary Outcome Measures:
  • testosterone levels [ Time Frame: one year ] [ 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


Biospecimen Retention:   Samples Without DNA

Blood hormone levels


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (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.

  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

Contacts
Contact: Christine M Vaccaro, DO 513-862-7265 christine_vaccaro@trihealth.com
Contact: Angie Fellner, PhD 513-862-2330 angie_fellner@trihealth.com

Locations
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Principal Investigator: Christine M Vaccaro, DO         
Sub-Investigator: Dani Zoorob, MD         
Sub-Investigator: Catrina Crisp, MD         
Sub-Investigator: Maria Estanol, MD         
Sub-Investigator: Angie Fellner, PhD         
Sub-Investigator: Steven Kleeman, MD         
Sub-Investigator: Rachel Pauls, MD         
Sponsors and Collaborators
TriHealth Inc.
Hatton Institute for Research and Education
Investigators
Principal Investigator: Christine M Vaccaro, DO Good Samaritan Hospital
  More Information

No publications provided

Responsible Party: Dr Christine Vaccaro, Trihealth
ClinicalTrials.gov Identifier: NCT01195701     History of Changes
Other Study ID Numbers: 10063
Study First Received: September 3, 2010
Last Updated: July 20, 2011
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 October 23, 2014