Effects of Caffeine on Women's Sexual Arousal

Sexual Behavior Clinical Trial

Official title:

The Effects of Caffeine on Female Genital Arousal

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01242046
• Other study ID #: 2010-07-0070
• Status: Withdrawn
• Phase: N/A
• First received: November 15, 2010
• Last updated: May 26, 2015

Study information

• Verified date: May 2015
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sexual Behavior

Intervention

Dietary Supplement:
• Caffeine
400 mg of caffeine in tablet form
• Placebo
Inert tablet

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual arousal	Vaginal pulse amplitude, as measured by a vaginal photoplethysmograph	15 minutes post administration of drug or placebo	No

External Links

•   Laboratory website