Female Sexual DysfunctionNCT01195701

Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

An observational study of Female Sexual Dysfunction and Anorgasmia, run by TriHealth Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Female Sexual Dysfunction, Anorgasmia
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Sep 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
Healthy volunteers accepted
Adult

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

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Good Samaritan Hospital
Cincinnati, Ohio, 45220

Other trials in United States

About this study

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

Read the 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.

Conditions: Female Sexual Dysfunction, Anorgasmia
Keywords: female sexual dysfunction, anorgasmia, clitoral complex, pelvic MRI, testosterone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01195701
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Clitoral Measurements Using Pelvic MRI
All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.
Measured: Between day 1-14 (follicular phase) of menstrual cycle

Secondary outcomes (10)

Free Testosterone
Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements
Measured: Between day 1-14 (follicular phase) of menstrual cycle
Total Testosterone
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
Measured: Between day 1-14 (follicular phase) of menstrual cycle
Free Androgen Index
Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)
Measured: Between day 1-14 (follicular phase) of menstrual cycle
Female Sexual Function Index (FSFI) Total Score
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.
Measured: baseline visit
FSFI Desire
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.
Measured: baseline visit
FSFI Arousal
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.
Measured: baseline visit
FSFI Lubrication
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.
Measured: baseline visit
FSFI Orgasm
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.
Measured: baseline visit
FSFI Satisfaction
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.
Measured: baseline visit
FSFI Pain
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.
Measured: baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Sep 2012

First posted6 Sep 2010 (estimated)
Study startJul 2010
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01195701
Sponsor's protocol ID: 10063
Status last verified: Nov 2014
First submitted: 3 Sep 2010
Last updated: 3 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Female Sexual Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clitoral Location in Relation to Sexual Function Using Pelvic MRI: A Case-Control Study
ClinicalTrials.gov ID: NCT01195701
Acronym / sponsor ID: 10063
Conditions: Female Sexual Dysfunction, Anorgasmia
Keywords: female sexual dysfunction, anorgasmia, clitoral complex, pelvic MRI, testosterone
Study type: Observational
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: TriHealth Inc.University, hospital or other
Collaborators: TriHealth Hatton Research Institute
Study start: Jul 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 6 Sep 2010 (estimated)
Results: Posted 3 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Sexually active premenopausal females aged 18-55 years old presenting to private gynecology practice

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

Not sexually active
Homosexual orientation
Postmenopausal
Stage >2 pelvic organ prolapse (POP-Q measurements beyond hymen)
Urinary incontinence with coitus limiting sexual activity

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

10 secondary outcomes

Free Testosterone
Time frame: Between day 1-14 (follicular phase) of menstrual cycle
Total Testosterone
Time frame: Between day 1-14 (follicular phase) of menstrual cycle
Free Androgen Index
Time frame: Between day 1-14 (follicular phase) of menstrual cycle
Female Sexual Function Index (FSFI) Total Score
Time frame: baseline visit
FSFI Desire
Time frame: baseline visit
FSFI Arousal
Time frame: baseline visit
FSFI Lubrication
Time frame: baseline visit
FSFI Orgasm
Time frame: baseline visit
FSFI Satisfaction
Time frame: baseline visit
FSFI Pain
Time frame: baseline visit

Results and safety

Results posted to the registry on 3 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anorgasmia (Cases)	10	10
Normal Orgasmic Function	25	20

Primary outcome: Clitoral Measurements Using Pelvic MRI

Time frame: Between day 1-14 (follicular phase) of menstrual cycle. Mean (Standard Deviation). Unit: millimeters (mm)

Measure	Anorgasmia (Cases) n = 10	Normal Orgasmic Function n = 20
Glans distance, sagittal, mm	51.3 (7.6)	45.1 (5.7)
Body distance, sagittal, mm	29.4 (6.8)	20.6 (3.2)
Crura distance, medial axial, mm	24.2 (5.2)	28.3 (4.6)
Crura distance, lateral axial, mm	15.6 (6.1)	23.8 (3.7)
Total vaginal length, mm	84.5 (11.1)	94.9 (6.5)
Clitoris to skin distance, mm	26.6 (11.4)	27.0 (6.2)
Midurethra-midvagina distance, mm	13.3 (2.5)	12.6 (1)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anorgasmia (Cases)	0 of 10 (0%)	0 of 10 (0%)	Not reported
Normal Orgasmic Function	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine M Vaccaro, DO principal investigator

Good Samaritan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Female Sexual Dysfunction and Anorgasmia, run by TriHealth Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clitoral Measurements Using Pelvic MRI (time frame: Between day 1-14 (follicular phase) of menstrual cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01195701.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.