Effects of Caffeine on Women's Sexual Arousal

This study has been withdrawn prior to enrollment.
(Key personnel were reassigned to different project)
Sponsor:
Information provided by (Responsible Party):
Tierney Ahrold, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01242046
First received: November 15, 2010
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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 Intervention
Sexual Behavior
Dietary Supplement: Caffeine
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effects of Caffeine on Female Genital Arousal

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Sexual arousal [ Time Frame: 15 minutes post administration of drug or placebo ] [ Designated as safety issue: No ]
    Vaginal pulse amplitude, as measured by a vaginal photoplethysmograph


Estimated Enrollment: 30
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT01242046

Locations
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Corey A Pallatto, B.A. University of Texas at Austin
  More Information

Additional Information:
No publications provided

Responsible Party: Tierney Ahrold, Researcher, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01242046     History of Changes
Other Study ID Numbers: 2010-07-0070
Study First Received: November 15, 2010
Last Updated: October 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
female sexual arousal

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 22, 2014