NCT01242046

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

First QC Date

November 15, 2010

Last Update Submit

May 26, 2015

Conditions

Keywords

female sexual arousal

Outcome Measures

Primary Outcomes (1)

  • Sexual arousal

    Vaginal pulse amplitude, as measured by a vaginal photoplethysmograph

    15 minutes post administration of drug or placebo

Study Arms (2)

Caffeine

EXPERIMENTAL

Participants will ingest a tablet with 400 mg caffeine

Dietary Supplement: Caffeine

Placebo

PLACEBO COMPARATOR

Participants will ingest an inert placebo tablet

Dietary Supplement: Placebo

Interventions

CaffeineDIETARY_SUPPLEMENT

400 mg of caffeine in tablet form

Caffeine
PlaceboDIETARY_SUPPLEMENT

Inert tablet

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Links

MeSH Terms

Conditions

Sexual Behavior

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Corey A Pallatto, B.A.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations