The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Caffeine on Women's Sexual Arousal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01242046
Recruitment Status : Withdrawn (Key personnel were reassigned to different project)
First Posted : November 16, 2010
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Tierney Kyle Ahrold Lorenz, University of Texas at Austin

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 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.

Condition or disease Intervention/treatment Phase
Sexual Behavior Dietary Supplement: Caffeine Dietary Supplement: Placebo Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effects of Caffeine on Female Genital Arousal

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Caffeine
Participants will ingest a tablet with 400 mg caffeine
 Dietary Supplement: Caffeine
400 mg of caffeine in tablet form
Placebo Comparator: Placebo
Participants will ingest an inert placebo tablet
 Dietary Supplement: Placebo
Inert tablet


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sexual arousal [ Time Frame: 15 minutes post administration of drug or placebo ]
    Vaginal pulse amplitude, as measured by a vaginal photoplethysmograph


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242046


Locations
Layout table for location information
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
Layout table for investigator information
Principal Investigator: Corey A Pallatto, B.A. University of Texas at Austin
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Tierney Kyle Ahrold Lorenz, Researcher, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01242046    
Other Study ID Numbers: 2010-07-0070
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Tierney Kyle Ahrold Lorenz, University of Texas at Austin:
female sexual arousal
Additional relevant MeSH terms:
Layout table for MeSH terms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents