OHSU
Portland, Oregon, 97239, United States
NCT Number: NCT04396730
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.
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Notify Me18 year–35 year
Female
Interventional
Phase 4
Portland, Oregon, 97239, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a. If participants have a normal menstrual cycle after these events, they may be considered for enrollment
400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
Other names: Cannabidiol + OCP
Placebo will be administered daily along with oral contraceptives daily for 24 days.
Other names: Placebo + OCP
All participants will receive oral contraceptives
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Area under the plasma concentration vs time curve of ethinyl estradiol (EE)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Area under the plasma concentration vs time curve of ethinyl estradiol (EE)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Area under the plasma concentration vs time curve of levonorgestrel (LNG)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Area under the plasma concentration vs time curve of levonorgestrel (LNG)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Time to maximum measured plasma concentration of LNG and EE. (Tmax)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Time to maximum measured plasma concentration of LNG and EE. (Tmax)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Time to maximum measured plasma concentration of LNG and EE (Cmax)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Time to maximum measured plasma concentration of LNG and EE (Cmax)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Final time taken for plasma concentration of LNG and EE to be reduced by half (t1/2)
Time frame: 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)
Time frame: 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)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The first-order final elimination rate constant of EE and LNG
Time frame: At the end of Cycle 3 (each cycle is 28 days)
The first-order final elimination rate constant of EE and LNG
Oregon Health and Science University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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