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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The purpose of this study is to assess how Cannabidiol (CBD) impacts the effectiveness of oral contraceptive (birth control) pills and if CBD changes the possible side effects of birth control pills when CBD and birth control pills are taken at the same time.
This study explores the potential interaction between CBD and birth control pills by assessing serum levels of the contraceptive steroid hormones ethinyl estradiol and levonorgestrel in birth control pill users when they also use CBD.
Participants will be randomized to either the CBD or placebo for cycle one, followed by a washout cycle. For cycle three, participants will take the opposite of what they received in Cycle one. For example if they received CBD during cycle one they will take placebo for cycle 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo followed by cannabidiol | Placebo Comparator | Oral contraceptives will be taken daily for 24 days along with placebo (oral) once daily for cycle 1. During cycle 3, cannabidiol will be taken once daily along with OCPs. |
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| Cannabidiol follow Placebo | Experimental | Oral contraceptives will be taken daily for 24 days along with Cannabidiol 400mg once daily for cycle 1. During cycle 3. placebo will be taken once daily along with OCPs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol Oil | Drug | 400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration Ethinyl Estradiol | Area under the plasma concentration vs time curve of ethinyl estradiol (EE) | At the end of Cycle 1 (each cycle is 28 days) |
| Maximum plasma concentration Ethinyl Estradiol | Area under the plasma concentration vs time curve of ethinyl estradiol (EE) | At the end of Cycle 3 (each cycle is 28 days) |
| Maximum plasma concentration of Levonorgestrel | Area under the plasma concentration vs time curve of levonorgestrel (LNG) | At the end of Cycle 1 (each cycle is 28 days) |
| Maximum plasma concentration of Levonorgestrel | Area under the plasma concentration vs time curve of levonorgestrel (LNG) | At the end of Cycle 3 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum measured plasma concentration (Tmax) | Time to maximum measured plasma concentration of LNG and EE. (Tmax) | At the end of Cycle 1 (each cycle is 28 days) |
| Time to maximum measured plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
Active users of hormonal contraception
Pregnancy (less than 6 weeks prior), breastfeeding (less than 6 weeks prior),
a. If participants have a normal menstrual cycle after these events, they may be considered for enrollment
Any absolute/relative contraindications to EE and LNG (MEC category 3 or 4 [12]) including impaired liver function, history of deep venous thrombosis, hypertension (> 140/90), diabetes with vascular changes, migraines with aura or neurological changes, history of myocardial infarction, pulmonary embolus, stroke or breast cancer.
Use of CBD or THC products / Marijuana in the last 30 days
Use of a known CYP450 inhibitor or inducer (other medication)
BMI>25
Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
Impaired liver or renal function
Smoking/vaping/e-cigarettes
Prior bariatric surgery
Decisional impairment
Incarceration
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| Name | Affiliation | Role |
|---|---|---|
| Shaalini Ramanadhan, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D003277 | Contraceptives, Oral, Combined |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Double (Participant, Investigator)
|
| Placebo | Drug | Placebo will be administered daily along with oral contraceptives daily for 24 days. |
|
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| Combined oral contraceptive pill | Drug | All participants will receive oral contraceptives |
|
Time to maximum measured plasma concentration of LNG and EE. (Tmax)
| At the end of Cycle 3 (each cycle is 28 days) |
| Time to maximum measured plasma concentration (Cmax) | Time to maximum measured plasma concentration of LNG and EE (Cmax) | At the end of Cycle 1 (each cycle is 28 days) |
| Time to maximum measured plasma concentration (Cmax) | Time to maximum measured plasma concentration of LNG and EE (Cmax) | At the end of Cycle 3 (each cycle is 28 days) |
| Final time taken for plasma concentration to be reduced by half (t1/2) | Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2) | At the end of Cycle 1 (each cycle is 28 days) |
| Final time taken for plasma concentration to be reduced by half (t1/2) | Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2) | At the end of Cycle 3 (each cycle is 28 days) |
| The area under the plasma concentration of LNG and EE vs. time curve (AUC) | The area under the plasma concentration of LNG and EE vs. time curve (AUC) | At the end of Cycle 1 (each cycle is 28 days) |
| The area under the plasma concentration of LNG and EE vs. time curve (AUC) | The area under the plasma concentration of LNG and EE vs. time curve (AUC) | At the end of Cycle 3 (each cycle is 28 days) |
| The first-order final elimination rate constant of EE and LNG | The first-order final elimination rate constant of EE and LNG | At the end of Cycle 1 (each cycle is 28 days) |
| The first-order final elimination rate constant of EE and LNG | The first-order final elimination rate constant of EE and LNG | At the end of Cycle 3 (each cycle is 28 days) |
| D004338 |
| Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |