Status:
COMPLETED
Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Society of Family Planning
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief Summary
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 w...
Detailed Description
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 ex...
Eligibility Criteria
Inclusion
- Have regular menses (every 21-35 days)
- Not at risk for pregnancy (not sexually active, using a barrier method of birth control, using a copper IUD for birth control, have a partner with a vasectomy, have had a tubal ligation, or in a same sex relationship)
- Generally healthy women between the age of 18 to 35 years old
- English speaking
Exclusion
- Active users of hormonal contraception
- For combined methods, if they have recently stopped use, they must have had one normal menstrual cycle
- For prior Depo-Medroxyprogesterone Acetate users, they must be off of the medication for 2 months and be having regular menstrual cycles
- 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
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04396730
Start Date
April 8 2020
End Date
March 2 2022
Last Update
July 11 2023
Active Locations (1)
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1
OHSU
Portland, Oregon, United States, 97239