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New treatment option for Oral Hormonal Contraceptive Use
Official title Contraceptive Hormone and Reward Measurement (CHARM Study)
ClinicalTrials.gov ID: NCT05058872
What this study is testing
What is Levonorgestrel/ethinyl estradiol?
Levonorgestrel/ethinyl estradiol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for oral hormonal contraceptive use.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Presence or history of severe or unstable physical, neurological (per health history interview) or psychiatric disorders (assessed by Miniature...
- 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...
- Presence or history of any category 3 or 4 conditions or medications per the CDC's (Centers for Disease Control and Prevention) Medical Eligibility...
- 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);
See the full eligibility criteria
- 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;
- 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.
- 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...
- 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...
- 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...
- 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);
- 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.).
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.