Oral Hormonal Contraceptive UsePhase 4CHARMNCT05058872
Contraceptive Hormone and Reward Measurement (CHARM Study)
A Phase 4 study testing Levonorgestrel/ethinyl estradiol in people with Oral Hormonal Contraceptive Use and Neural Activity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing. Procedures: If participants agree to participate, the following will happen: 1. Eligibility visit (remote screening session) 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Hormonal Contraceptive Use, Neural Activity, Mood
- What is being tested?
- Levonorgestrel/ethinyl estradiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 and older;
- Right-handed;
- Assigned female at birth;
- Regular 21-35 day menstrual cycles for the past 6 months per self-report;
- In generally good health per self-report. Those with a chronic medical condition may participate at the discretion of the principal investigator if the condition is stable;
- Willingness to abstain from intercourse or use a non-hormonal back-up method of contraception (e.g., condoms) during the entire course of the study;
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- Negative urine drug screen, excepting marijuana or benzodiazepine that is being prescribed by a physician as a sleep aid, assessed at the baseline visit;
- Ability to abstain from caffeine and/or cannabis for 2 hours prior to functional Magnetic Resonance Imaging (fMRI) scan visits;
- Access to a reliable internet connection or cell phone data to complete daily questionnaires;
- For those wishing to complete study screening session remotely: access to a reliable internet connection, computer to complete electronic consent and a private space to complete the session.
Who cannot join
- Presence or history of severe or unstable physical, neurological (per health history interview) or psychiatric disorders (assessed by Miniature International Neuropsychiatric Interview (MINI) but per Diagnostic and Statistical Manual of Mental Disorders - fifth edition (DSM-V) criteria, and the discretion of the principal investigator);
- Lifetime history of psychotic disorders;
- History of substance use disorder that has not been in remission (as defined by a substance free period of at least one year). However, individuals with mild disorders, disorders solely limited to cannabis, and/or those who have achieved close to one year of remission may be eligible at the discretion of the PI;
- Presence or history of any category 3 or 4 conditions or medications per the CDC's (Centers for Disease Control and Prevention) Medical Eligibility Criteria for Contraceptive Use pertaining to combined hormonal contraceptive methods as per self-report and reviewed by the principal investigator;
- Irregular menstrual periods per self-report;
- Any current tobacco smoking (former smokers are eligible so long as their quit date was greater than one year ago);
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- Any personal or family history of a venous thromboembolism;
- Known diagnosis of hypertensive disorder;
- Any current or past history of malignancy;
- Migraines with aura;
- Systolic blood pressure greater than or equal to 140 or diastolic pressure greater than or equal to 90 taken at baseline visit;
- Currently nursing an infant;
- Known chromosomal or hormonal disorder affecting sex steroids;
- Use of hormonal contraceptives currently or in the past 3 months, or use of medications that directly affect sex hormones (i.e. gonadotropin releasing hormone agonists, selective estrogen receptor modifiers);
- Current pregnancy or pregnancy/delivery in the past six months;
- Intention to become pregnant during study participation;
- Current use of psychotropic medication;
- Claustrophobia;
- Metal in body unsafe for magnetic resonance imaging;
- Weight over 300 pounds;
- Conditions that would make magnetic resonance imaging unsafe for participants (i.e. aneurysm clip, cardiac pacemaker, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
Andrew M Novick, MD PhD, 2672593730, andrew.m.novick@cuanschutz.edu
About this study
Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing.
Procedures: If participants agree to participate, the following will happen:
- Eligibility visit (remote screening session)
- If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in.
- During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device.
- Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.
Read the detailed description
Hypothesis:
The principal investigator hypothesizes that treatment with oral contraceptives, specifically a combination of a synthetic estrogen and progestin, in adult females will result in deficits in reward processing.
Specific Aims:
- Subjective ratings of mood and hedonic function. Based on previous evidence, the principal investigator hypothesizes that H1a) treatment with a hormonal oral contraceptive will result in decreased self-reports of sexual function and interest/enjoyment in non-sexual pleasurable activities as measured by the Sexual Function Questionnaire and Dimensional Anhedonia Rating Scale, respectively.
- Neural activity in reward processing areas during an incentive delay task. Via functional magnetic resonance imaging, neural activity will be measured during both the anticipation and receipt of a pleasurable image (erotica, pleasant images of the outdoors, and "cute" animals). Activation of nucleus accumbens and ventromedial pre-frontal cortex is positively associated with feelings of anticipation and pleasure, respectively (10). The principal investigator hypothesizes that H2) treatment with a hormonal oral contraceptive will result in decreased activity in these regions, consistent with decreased reward anticipation and responsiveness.
- Being tested
- Levonorgestrel/ethinyl estradiol, Placebo
- Keywords
- oral contraceptives, mood, reward processing, hedonic function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel/ethinyl estradiolDrug
Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel/ethinyl estradiol | Experimental | Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg - once a day for 21 days Receives: Drug: Levonorgestrel/ethinyl estradiol |
| Placebo | Placebo comparator | Placebo once a day for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ratings of anhedonia after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Dimensional Anhedonia Rating Scale
The Dimensional Anhedonia Rating Scale is validated measure of anhedonia (lack of pleasure, desire, and motivation). Scores range from 17 to 85 with higher scores reflecting a better outcome/less anhedonia
Measured: Baseline, 21 days post-intervention
Change in ratings of sexual function after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Female Sexual Function Index.
The Female Sexual Function Index is a validated questionnaire of various domains of sexual functioning in women. Scores range from 2 to 36, with higher scores reflecting better outcomes/better sexual function.
Measured: Baseline, 21 days post-intervention
Change in Blood Oxygen Level Dependent (BOLD) Signal after 21 days of treatment with either levonorgestrel/ethinyl estradiol or placebo
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signal in the brain will be measured during a reward task both at baseline and after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo.
Measured: Baseline, 21 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Hormonal Contraceptive UseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Novick, MD PhD, Principal investigator, University of Colorado Denver Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058872
- Sponsor's protocol ID
- 21-3530
- Acronym
- CHARM
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Hormone and Reward Measurement (CHARM Study)
- ClinicalTrials.gov ID
- NCT05058872
- Acronym / sponsor ID
- CHARM / 21-3530
- Keywords
- oral contraceptives, mood, reward processing, hedonic function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Sep 2021 (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.
Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing.
Procedures: If participants agree to participate, the following will happen:
- Eligibility visit (remote screening session)
- If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in.
- During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device.
- Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.
Detailed description
Hypothesis:
The principal investigator hypothesizes that treatment with oral contraceptives, specifically a combination of a synthetic estrogen and progestin, in adult females will result in deficits in reward processing.
Specific Aims:
- Subjective ratings of mood and hedonic function. Based on previous evidence, the principal investigator hypothesizes that H1a) treatment with a hormonal oral contraceptive will result in decreased self-reports of sexual function and interest/enjoyment in non-sexual pleasurable activities as measured by the Sexual Function Questionnaire and Dimensional Anhedonia Rating Scale, respectively.
- Neural activity in reward processing areas during an incentive delay task. Via functional magnetic resonance imaging, neural activity will be measured during both the anticipation and receipt of a pleasurable image (erotica, pleasant images of the outdoors, and "cute" animals). Activation of nucleus accumbens and ventromedial pre-frontal cortex is positively associated with feelings of anticipation and pleasure, respectively (10). The principal investigator hypothesizes that H2) treatment with a hormonal oral contraceptive will result in decreased activity in these regions, consistent with decreased reward anticipation and responsiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel/ethinyl estradiol | Experimental | Drug: Levonorgestrel/ethinyl estradiolLevonorgestrel 0.15mg/ethinyl estradiol 0.03mg - once a day for 21 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once a day for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 and older;
- Right-handed;
- Assigned female at birth;
- Regular 21-35 day menstrual cycles for the past 6 months per self-report;
- In generally good health per self-report. Those with a chronic medical condition may participate at the discretion of the principal investigator if the condition is stable;
Key exclusion criteria (21 listed)
- Presence or history of severe or unstable physical, neurological (per health history interview) or psychiatric disorders (assessed by Miniature International Neuropsychiatric Interview (MINI) but per Diagnostic and Statistical Manual of Mental Disorders - fifth edition (DSM-V) criteria, and the discretion of the principal investigator);
- Lifetime history of psychotic disorders;
- History of substance use disorder that has not been in remission (as defined by a substance free period of at least one year). However, individuals with mild disorders, disorders solely limited to cannabis, and/or those who have achieved close to one year of remission may be eligible at the discretion of the PI;
- Presence or history of any category 3 or 4 conditions or medications per the CDC's (Centers for Disease Control and Prevention) Medical Eligibility Criteria for Contraceptive Use pertaining to combined hormonal contraceptive methods as per self-report and reviewed by the principal investigator;
- Irregular menstrual periods per self-report;
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 |
|---|---|---|
| Levonorgestrel/ethinyl estradiolLevonorgestrel 0.15mg/ethinyl estradiol 0.03mg | Drug | Levonorgestrel/ethinyl estradiol |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Change in ratings of anhedonia after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Dimensional Anhedonia Rating Scale
Time frame: Baseline, 21 days post-intervention
The Dimensional Anhedonia Rating Scale is validated measure of anhedonia (lack of pleasure, desire, and motivation). Scores range from 17 to 85 with higher scores reflecting a better outcome/less anhedonia
Change in ratings of sexual function after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Female Sexual Function Index.
Time frame: Baseline, 21 days post-intervention
The Female Sexual Function Index is a validated questionnaire of various domains of sexual functioning in women. Scores range from 2 to 36, with higher scores reflecting better outcomes/better sexual function.
Change in Blood Oxygen Level Dependent (BOLD) Signal after 21 days of treatment with either levonorgestrel/ethinyl estradiol or placebo
Time frame: Baseline, 21 days post-intervention
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signal in the brain will be measured during a reward task both at baseline and after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- 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.
Andrew M Novick, MD PhD principal investigator
University of Colorado Denver Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levonorgestrel/ethinyl estradiol in people with Oral Hormonal Contraceptive Use and Neural Activity, run by University of Colorado, Denver 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 10 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew M Novick, MD PhD (2672593730, andrew.m.novick@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ratings of anhedonia after 21 days of receiving either levonorgestrel/ethinyl estradiol or placebo as measured by the Dimensional Anhedonia Rating Scale (time frame: Baseline, 21 days post-intervention). The study lists 3 primary outcomes in all. 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 4 Nov 2024.