NCT05058872 Contraceptive Hormone and Reward Measurement (CHARM Study)
| NCT ID | NCT05058872 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Oral Hormonal Contraceptive Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 144 participants in total. It began in 2021-10-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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. 3. 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. 4. 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 and older; 2. Right-handed; 3. Assigned female at birth; 4. Regular 21-35 day menstrual cycles for the past 6 months per self-report; 5. 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; 6. 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; 7. Negative urine drug screen, excepting marijuana or benzodiazepine that is being prescribed by a physician as a sleep aid, assessed at the baseline visit; 8. Ability to abstain from caffeine and/or cannabis for 2 hours prior to functional Magnetic Resonance Imaging (fMRI) scan visits; 9. Access to a reliable internet connection or cell phone data to complete daily questionnaires; 10. 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. Exclusion Criteria: 1. 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); 2. Lifetime history of psychotic disorders; 3. 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; 4. 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; 5. Irregular menstrual periods per self-report; 6. Any current tobacco smoking (former smokers are eligible so long as their quit date was greater than one year ago); 7. Any personal or family history of a venous thromboembolism; 8. Known diagnosis of hypertensive disorder; 9. Any current or past history of malignancy; 10. Migraines with aura; 11. Systolic blood pressure greater than or equal to 140 or diastolic pressure greater than or equal to 90 taken at baseline visit; 12. Currently nursing an infant; 13. Known chromosomal or hormonal disorder affecting sex steroids; 14. 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); 15. Current pregnancy or pregnancy/delivery in the past six months; 16. Intention to become pregnant during study participation; 17. Current use of psychotropic medication; 18. Claustrophobia; 19. Metal in body unsafe for magnetic resonance imaging; 20. Weight over 300 pounds; 21. Conditions that would make magnetic resonance imaging unsafe for participants (i.e. aneurysm clip, cardiac pacemaker, etc.).
Contact & Investigator
Andrew M Novick, MD PhD
PRINCIPAL INVESTIGATOR
University of Colorado Denver Anschutz Medical Campus
Frequently Asked Questions
Who can join the NCT05058872 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Oral Hormonal Contraceptive Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05058872 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05058872 currently recruiting?
Yes, NCT05058872 is actively recruiting participants. Contact the research team at andrew.m.novick@cuanschutz.edu for enrollment information.
Where is the NCT05058872 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05058872 clinical trial?
NCT05058872 is sponsored by University of Colorado, Denver. The principal investigator is Andrew M Novick, MD PhD at University of Colorado Denver Anschutz Medical Campus. The trial plans to enroll 144 participants.