Female Sexual Arousal DisorderPhase 1NCT05685407
Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women
A Phase 1 study testing Caffeine in people with Female Sexual Arousal Disorder, run by University of Texas at Austin at 1 site in United States.
Trial summary
Antidepressants have negative effects on genital arousal function that hinder quality of life and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation through exercise has shown promising results for improving antidepressant-induced genital arousal dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Female Sexual Arousal Disorder
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 15 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between the of ages 18-55
- Fluent in English
- Experience antidepressant-induced arousal difficulties
- Experience regular menstrual periods (i.e., not perimenopausal or menopausal)
Who cannot join
- A history or current diagnosis of panic attacks or panic disorder
- A history or current diagnosis of sexually transmitted disease(s)
- A history of major pelvic surgery that caused nerve damage
- Currently taking beta blockers, antipsychotics, anti-anxiolytics, hormonal contraceptives (unless the participant has been taking it for over 3 months), or any other medical treatment to enhance sexual response
- Other medical conditions or procedures that would preclude the participant's participation in the study (e.g., urinary tract infection, neurological impairment due to diabetes or stroke, or spinal cord damage)
- A history of childhood sexual abuse (CSA) that occurred prior to age 16
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin, Sexual Psychophysiology Laboratory
Austin, Texas, 78712
About this study
Antidepressants have negative effects on genital arousal function that hinder quality of life and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation through exercise has shown promising results for improving antidepressant-induced genital arousal dysfunction. It is feasible that caffeine - an SNS stimulant - could improve antidepressant-induced genital arousal difficulties if ingested prior to sex. The goal of the present pilot study is to examine whether the acute administration of 300mg of caffeine increases genital arousal in women experiencing antidepressant-induced genital arousal difficulties. Women will attend two counterbalanced sessions in which they ingest either 300mg caffeine or placebo. Fifteen minutes after ingestion, they will view an erotic film while their heart rate and genital sexual arousal are measured. Caffeine could serve as a low-cost, widely accessible intervention with minimal side effects if efficacy is shown.
- Conditions
- Female Sexual Arousal Disorder
- Being tested
- Caffeine, Placebo
- Keywords
- female sexual dysfunction, female sexual arousal disorder, caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.
PlaceboOther
A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules. Receives: Drug: Caffeine |
| Placebo | Placebo comparator | During one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal pulse amplitude via vaginal photoplethysmography
Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow
Measured: 15 minutes post-ingestion of caffeine and placebo
Secondary outcomes (1)
Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale
Discrete measurement of the construct was calculated by summing the scores of the three original subjective sexual arousal items from Heiman and Rowland's (1983) Film Scale, which assesses sexual arousal as well as positive and negative affect in response to an erotic film. These three items include an assessment of overall "sexual arousal," a sense of "mental sexual arousal," and one reverse-scored item on feeling "sexually turned off." On two occasions during the experiment (immediately following the first neutral-erotic film sequence and immediately following the second neutral-erotic film sequence), participants rated the degree to which they experienced each of the three items on a 7-point Likert scale (where higher scores indicate higher subjective sexual arousal), and then the three scores were combined into a single subjective sexual arousal score for each of the two time points.
Measured: 30 minutes post-ingestion of caffeine and placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jan 2023
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual Arousal DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy M Meston, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685407
- Sponsor's protocol ID
- 00002778
- Status last verified
- Jun 2023
- First submitted
- 5 Jan 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women
- ClinicalTrials.gov ID
- NCT05685407
- Acronym / sponsor ID
- 00002778
- Conditions
- Female Sexual Arousal Disorder
- Keywords
- female sexual dysfunction, female sexual arousal disorder, caffeine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antidepressants have negative effects on genital arousal function that hinder quality of life and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation through exercise has shown promising results for improving antidepressant-induced genital arousal dysfunction. It is feasible that caffeine - an SNS stimulant - could improve antidepressant-induced genital arousal difficulties if ingested prior to sex. The goal of the present pilot study is to examine whether the acute administration of 300mg of caffeine increases genital arousal in women experiencing antidepressant-induced genital arousal difficulties. Women will attend two counterbalanced sessions in which they ingest either 300mg caffeine or placebo. Fifteen minutes after ingestion, they will view an erotic film while their heart rate and genital sexual arousal are measured. Caffeine could serve as a low-cost, widely accessible intervention with minimal side effects if efficacy is shown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: CaffeineDuring one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules. |
| Placebo | Placebo comparator | Other: PlaceboDuring one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the of ages 18-55
- Fluent in English
- Experience antidepressant-induced arousal difficulties
- Experience regular menstrual periods (i.e., not perimenopausal or menopausal)
Key exclusion criteria (6 listed)
- A history or current diagnosis of panic attacks or panic disorder
- A history or current diagnosis of sexually transmitted disease(s)
- A history of major pelvic surgery that caused nerve damage
- Currently taking beta blockers, antipsychotics, anti-anxiolytics, hormonal contraceptives (unless the participant has been taking it for over 3 months), or any other medical treatment to enhance sexual response
- Other medical conditions or procedures that would preclude the participant's participation in the study (e.g., urinary tract infection, neurological impairment due to diabetes or stroke, or spinal cord damage)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder. | Drug | Caffeine |
| PlaceboA placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder. | Other | Placebo |
Primary outcome
Vaginal pulse amplitude via vaginal photoplethysmography
Time frame: 15 minutes post-ingestion of caffeine and placebo
Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow
1 secondary outcome
Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale
Time frame: 30 minutes post-ingestion of caffeine and placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy M Meston, PhD principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caffeine in people with Female Sexual Arousal Disorder, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal pulse amplitude via vaginal photoplethysmography (time frame: 15 minutes post-ingestion of caffeine and placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.