Contraceptive Hormone and Reward Measurement (CHARM Study)

NCT05058872 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-3530
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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. 1.Eligibility visit (remote screening session)
2. 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. 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. 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.

Conditions

Oral Hormonal Contraceptive Use; Neural Activity; Mood; Hedonic Function

Keywords

oral contraceptives; mood; reward processing; hedonic function

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Baseline, 21 days post-intervention

Study Arms (2)

Levonorgestrel/ethinyl estradiol

EXPERIMENTAL

Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg - once a day for 21 days

Drug: Levonorgestrel/ethinyl estradiol

Placebo

PLACEBO COMPARATOR

Placebo once a day for 21 days

Drug: Placebo

Interventions

Levonorgestrel/ethinyl estradiol DRUG

Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg

Levonorgestrel/ethinyl estradiol

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Andrew M Novick, MD PhD

  University of Colorado Denver Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew M Novick, MD PhD

CONTACT

2672593730; andrew.m.novick@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)