Sexual BehaviorNCT01242046
Effects of Caffeine on Women's Sexual Arousal
A study testing Caffeine in people with Sexual Behavior, run by University of Texas at Austin at 1 site in United States.
Trial summary
The key research question in this study is whether or not caffeine facilitates genital sexual arousal in women in the presence of an external erotic stimulus. Caffeine's impact on the human sexual response cycle has yet to be studied in the field, so the goal is to determine if this substance will have any impact on… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 or older
- Heterosexual
- Experiencing regular menstrual cycles (not more than 1 missed menstrual period in the past 6 months).
- Currently involved in a stable, sexually active relationship.
- Fluent in the English language.
Who cannot join
- Self-report of sexual aversion or distress; or of distress related to a history of unwanted or coercive sexual contact.
- Perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or clinically significant untreated renal or endocrine disease.
- History of HIV infection or active, untreated pelvic, vaginal, or urinary tract infection including sexually transmitted diseases such as chlamydia, genital herpes, gonorrhea, or syphilis.
- Previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
- Self-report of an untreated psychosis (e.g., bipolar disorder or schizophrenia).
- Women who do not use caffeine products regularly (i.e., on a daily basis).
- Women receiving any of the following medications will be excluded from the study, as they have been shown to alter sexual function or arousal response: Dehydroepiandrosterone (DHEA), testosterone and other androgens, estrogens (except oral contraceptives), progesterone, tamoxifen, raloxifene, and other selective estrogen receptor modulators (SERMs), Beta blockers or other drugs that affect the autonomic nervous system and/or cardiovascular system, any approved or experimental medications or treatments used to enhance the sexual response (e.g., sildenafil), and antidepressants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Caffeine on Female Genital Arousal
The key research question in this study is whether or not caffeine facilitates genital sexual arousal in women in the presence of an external erotic stimulus. Caffeine's impact on the human sexual response cycle has yet to be studied in the field, so the goal is to determine if this substance will have any impact on genital arousal well as potentially identify the mechanisms underlying its ability to do so. Considering that this will be a single blind study, a key goal of the project is to determine how participant expectations regarding what they ingest will impact their subjective sexual arousal. At present, we hypothesize that, as caffeine's stimulant properties increase a human's heart rate and blood pressure, caffeine intake will facilitate genital arousal.
- Conditions
- Sexual Behavior
- Being tested
- Caffeine, Placebo
- Keywords
- female sexual arousal
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
400 mg of caffeine in tablet form
PlaceboDietary supplement
Inert tablet
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Participants will ingest a tablet with 400 mg caffeine Receives: Dietary Supplement: Caffeine |
| Placebo | Placebo comparator | Participants will ingest an inert placebo tablet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual arousal
Vaginal pulse amplitude, as measured by a vaginal photoplethysmograph
Measured: 15 minutes post administration of drug or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
Why it stopped: Key personnel were reassigned to different project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tierney Kyle Ahrold Lorenz, University of Texas at Austin
- Investigators
- Corey A Pallatto, B.A., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242046
- Sponsor's protocol ID
- 2010-07-0070
- Status last verified
- May 2015
- First submitted
- 15 Nov 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine on Female Genital Arousal
- ClinicalTrials.gov ID
- NCT01242046
- Acronym / sponsor ID
- 2010-07-0070
- Conditions
- Sexual Behavior
- Keywords
- female sexual arousal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Key personnel were reassigned to different project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The key research question in this study is whether or not caffeine facilitates genital sexual arousal in women in the presence of an external erotic stimulus. Caffeine's impact on the human sexual response cycle has yet to be studied in the field, so the goal is to determine if this substance will have any impact on genital arousal well as potentially identify the mechanisms underlying its ability to do so. Considering that this will be a single blind study, a key goal of the project is to determine how participant expectations regarding what they ingest will impact their subjective sexual arousal. At present, we hypothesize that, as caffeine's stimulant properties increase a human's heart rate and blood pressure, caffeine intake will facilitate genital arousal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Dietary Supplement: CaffeineParticipants will ingest a tablet with 400 mg caffeine |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will ingest an inert placebo tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 or older
- Heterosexual
- Experiencing regular menstrual cycles (not more than 1 missed menstrual period in the past 6 months).
- Currently involved in a stable, sexually active relationship.
- Fluent in the English language.
Key exclusion criteria (7 listed)
- Self-report of sexual aversion or distress; or of distress related to a history of unwanted or coercive sexual contact.
- Perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or clinically significant untreated renal or endocrine disease.
- History of HIV infection or active, untreated pelvic, vaginal, or urinary tract infection including sexually transmitted diseases such as chlamydia, genital herpes, gonorrhea, or syphilis.
- Previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
- Self-report of an untreated psychosis (e.g., bipolar disorder or schizophrenia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine400 mg of caffeine in tablet form | Dietary supplement | Caffeine |
| PlaceboInert tablet | Dietary supplement | Placebo |
Primary outcome
Sexual arousal
Time frame: 15 minutes post administration of drug or placebo
Vaginal pulse amplitude, as measured by a vaginal photoplethysmograph
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Related trials for Sexual Behavior
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
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.
Corey A Pallatto, B.A. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Sexual Behavior, run by University of Texas at Austin 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 May 2015. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sexual arousal (time frame: 15 minutes post administration of drug or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2015.