Women's Sexual HealthNCT02865096
The Correlation of Women's Sexual Health and Marijuana Use
An observational study of Women's Sexual Health, run by St. Louis University at 1 site in United States.
Trial summary
This study is attempting to determine whether there is any effect (worsening or improvement of sexual function) after marijuana consumption. Both users and non users of marijuana will be given the opportunity to participate by completing a questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Sexual Health
- How many people
- 373 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 1 Feb 2017
- Phase
- Observational
- 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 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient participants will be asked upon check-in at their ob/gyn office whether they would like to participate in the questionnaire study. Patients will be asked to complete their questionnaire in the exam room of the ob/gyn practice. Patients who choose to voluntarily participate in the study, will be instructed to place their anonymous questionnaire in a provided blank envelope and seal it as to ensure confidentiality, then return their completed questionnaire to the front desk and place the sealed envelope in a lock box themselves.
Who may be able to join
- Female ages 18 to 90 years old, agree to fill out questionnaire
Who cannot join
- Male, Female age less than 18 or over 90 years old, decline to fill out questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
This study is attempting to determine whether there is any effect (worsening or improvement of sexual function) after marijuana consumption. Both users and non users of marijuana will be given the opportunity to participate by completing a questionnaire.
Read the detailed description
Marijuana is the most commonly used illicit drug (19.8 million past-month users) according to the 2013 National Survey on Drug Use and Health (NSDUH).
There is a current movement towards the legalization of marijuana in various states and there are numerous claims of potential uses in medicine.
The internet is rich with nonscientific, non-evidence based information regarding the effects of marijuana on the sex lives of women. However, surprisingly little scientific research has been done on it.
Cannabis use and sexual function Endocannabinoids, which are structurally similar to cannabis (marijuana) help regulate a number of motivated behaviors and emotional states, including sexual function. There are a variety of ways that cannabinoids interact with the hormones and neurotransmitters that affect sexual behavior. This interaction has not been clearly elucidated but studies in rats have helped to clarify the relationship between cannabinoids and the hormones and neurotransmitters that affect sexual behavior.
In male rats, administration of tetrahydrocannabinol (THC, the psychoactive compound in marijuana) reduced sexual motivation. In female rats, the relationship between THC and sexual behavior is less clear. found that giving female rats a low dose of THC increased their receptivity to copulation. However a high dose interfered with receptivity, also found that THC stimulated receptivity and increased proceptivity ("courting behavior") in female hamsters.
Lopez et al found that in rats, giving a cannabinoid receptor blocker, increased sexual motivation during the estrous cycle. They then found that ovariectomized rats given a cannabinoid receptor agonist, had reduced sexual motivation. When exogenous estrogen and progesterone were given, this effect was attenuated.
The exact mechanism by which THC affects sexual function in women is unknown. It is known that THC and the hypothalamic-pituitary-gonadal (HPG) axis, which controls the sex hormones, interact with eachother. Acute administration of THC has been shown to inhibit LH and PRL secretion from the anterior pituitary in males and females. In females, high dose of THC can interfere with estrous and menstrual cycle timing and can delay or prevent ovulation. Cannabinoids inhibit or interfere with activity of the HPG axis and reduce secretion of several hormones which tend to have an inhibitory impact on sexual behavior.
It is known that dopamine is a key prosexual modulator in normal excitatory female sexual function. It is also known that the major effects of THC in the central nervous system are mediated by cannabinoid receptors. These receptors have been shown to enhance dopamine (Lazenka et al, 2015), which may be another pathway by which marijuana affects sexual function.
Human studies are limited. Questioned regular male and female marijuana users about their opinions regarding changes in the sexual experience when using marijuana. They found that when marijuana affects the sexual experience, it affects it positively. Marijuana did appear to increase desire mildly and enhances the quality of orgasm.
There are several links between THC and hormonal and neurotransmitter pathways that play a role in sexual function and dysfunction, providing a theoretical way that THC may alter sexual functioning. These links need to be more clearly studied and elucidated.
- Conditions
- Women's Sexual Health
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the relationship between marijuana consumption and sexual function
Study participants will fill out one anonymous questionnaire and deposit the completed questionnaire themselves in a locked box.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's Sexual HealthStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Becky Lynn, MD, St. Louis University
- Investigators
- Becky Lynn, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865096
- Sponsor's protocol ID
- 26860
- Status last verified
- Dec 2017
- First submitted
- 4 Aug 2016
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Women's Sexual Health and Marijuana Use
- ClinicalTrials.gov ID
- NCT02865096
- Acronym / sponsor ID
- 26860
- Conditions
- Women's Sexual Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
This study is attempting to determine whether there is any effect (worsening or improvement of sexual function) after marijuana consumption. Both users and non users of marijuana will be given the opportunity to participate by completing a questionnaire.
Detailed description
Marijuana is the most commonly used illicit drug (19.8 million past-month users) according to the 2013 National Survey on Drug Use and Health (NSDUH).
There is a current movement towards the legalization of marijuana in various states and there are numerous claims of potential uses in medicine.
The internet is rich with nonscientific, non-evidence based information regarding the effects of marijuana on the sex lives of women. However, surprisingly little scientific research has been done on it.
Cannabis use and sexual function Endocannabinoids, which are structurally similar to cannabis (marijuana) help regulate a number of motivated behaviors and emotional states, including sexual function. There are a variety of ways that cannabinoids interact with the hormones and neurotransmitters that affect sexual behavior. This interaction has not been clearly elucidated but studies in rats have helped to clarify the relationship between cannabinoids and the hormones and neurotransmitters that affect sexual behavior.
In male rats, administration of tetrahydrocannabinol (THC, the psychoactive compound in marijuana) reduced sexual motivation. In female rats, the relationship between THC and sexual behavior is less clear. found that giving female rats a low dose of THC increased their receptivity to copulation. However a high dose interfered with receptivity, also found that THC stimulated receptivity and increased proceptivity ("courting behavior") in female hamsters.
Lopez et al found that in rats, giving a cannabinoid receptor blocker, increased sexual motivation during the estrous cycle. They then found that ovariectomized rats given a cannabinoid receptor agonist, had reduced sexual motivation. When exogenous estrogen and progesterone were given, this effect was attenuated.
The exact mechanism by which THC affects sexual function in women is unknown. It is known that THC and the hypothalamic-pituitary-gonadal (HPG) axis, which controls the sex hormones, interact with eachother. Acute administration of THC has been shown to inhibit LH and PRL secretion from the anterior pituitary in males and females. In females, high dose of THC can interfere with estrous and menstrual cycle timing and can delay or prevent ovulation. Cannabinoids inhibit or interfere with activity of the HPG axis and reduce secretion of several hormones which tend to have an inhibitory impact on sexual behavior.
It is known that dopamine is a key prosexual modulator in normal excitatory female sexual function. It is also known that the major effects of THC in the central nervous system are mediated by cannabinoid receptors. These receptors have been shown to enhance dopamine (Lazenka et al, 2015), which may be another pathway by which marijuana affects sexual function.
Human studies are limited. Questioned regular male and female marijuana users about their opinions regarding changes in the sexual experience when using marijuana. They found that when marijuana affects the sexual experience, it affects it positively. Marijuana did appear to increase desire mildly and enhances the quality of orgasm.
There are several links between THC and hormonal and neurotransmitter pathways that play a role in sexual function and dysfunction, providing a theoretical way that THC may alter sexual functioning. These links need to be more clearly studied and elucidated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient participants will be asked upon check-in at their ob/gyn office whether they would like to participate in the questionnaire study. Patients will be asked to complete their questionnaire in the exam room of the ob/gyn practice. Patients who choose to voluntarily participate in the study, will be instructed to place their anonymous questionnaire in a provided blank envelope and seal it as to ensure confidentiality, then return their completed questionnaire to the front desk and place the sealed envelope in a lock box themselves.
Key inclusion criteria (1 listed)
- Female ages 18 to 90 years old, agree to fill out questionnaire
Key exclusion criteria (1 listed)
- Male, Female age less than 18 or over 90 years old, decline to fill out questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the relationship between marijuana consumption and sexual function
Time frame: 1 day
Study participants will fill out one anonymous questionnaire and deposit the completed questionnaire themselves in a locked box.
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 7 Dec 2017.
- 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.
Becky Lynn, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women's Sexual Health, run by St. Louis University 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 1 inclusion and 1 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 7 Dec 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Evaluate the relationship between marijuana consumption and sexual function (time frame: 1 day). 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 7 Dec 2017.