- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242046
Effects of Caffeine on Women's Sexual Arousal
May 26, 2015 updated by: Tierney Kyle Ahrold Lorenz, University of Texas at Austin
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States, 78712
- University of Texas at Austin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caffeine
Participants will ingest a tablet with 400 mg caffeine
|
400 mg of caffeine in tablet form
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Placebo Comparator: Placebo
Participants will ingest an inert placebo tablet
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Inert tablet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual arousal
Time Frame: 15 minutes post administration of drug or placebo
|
Vaginal pulse amplitude, as measured by a vaginal photoplethysmograph
|
15 minutes post administration of drug or placebo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Corey A Pallatto, B.A., University of Texas at Austin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 15, 2010
First Submitted That Met QC Criteria
November 15, 2010
First Posted (Estimate)
November 16, 2010
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-07-0070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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