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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levonorgestrel/ethinyl estradiol | Experimental | Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg - once a day for 21 days |
|
| Placebo | Placebo Comparator | Placebo once a day for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel/ethinyl estradiol | Drug | Levonorgestrel 0.15mg/ethinyl estradiol 0.03mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew M Novick, MD PhD | Contact | 2672593730 | andrew.m.novick@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew M Novick, MD PhD | University of Colorado Denver Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
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| Placebo | Drug | Placebo comparator |
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |