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Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction

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ClinicalTrials.gov Identifier: NCT04396730
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Shaalini Ramanadhan, Oregon Health and Science University

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 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.


Condition or disease Intervention/treatment Phase
Contraception Drug: Cannabidiol Oil Drug: Placebo Drug: Combined oral contraceptive pill Phase 4

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 example if they received CBD during cycle one they will take placebo for cycle 3.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Placebo Comparator: Placebo followed by cannabidiol
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.
Drug: Cannabidiol Oil
400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Cannabidiol + OCP

Drug: Placebo
Placebo will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Placebo + OCP

Drug: Combined oral contraceptive pill
All participants will receive oral contraceptives

Experimental: Cannabidiol follow Placebo
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.
Drug: Cannabidiol Oil
400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Cannabidiol + OCP

Drug: Placebo
Placebo will be administered daily along with oral contraceptives daily for 24 days.
Other Name: Placebo + OCP

Drug: Combined oral contraceptive pill
All participants will receive oral contraceptives




Primary Outcome Measures :
  1. Maximum plasma concentration Ethinyl Estradiol [ 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)

  2. Maximum plasma concentration Ethinyl Estradiol [ 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)

  3. Maximum plasma concentration of Levonorgestrel [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Area under the plasma concentration vs time curve of levonorgestrel (LNG)

  4. Maximum plasma concentration of Levonorgestrel [ Time Frame: At the end of Cycle 3 (each cycle is 28 days) ]
    Area under the plasma concentration vs time curve of levonorgestrel (LNG)


Secondary Outcome Measures :
  1. Time to maximum measured plasma concentration (Tmax) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Time to maximum measured plasma concentration of LNG and EE. (Tmax)

  2. Time to maximum measured plasma concentration (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)

  3. Time to maximum measured plasma concentration (Cmax) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Time to maximum measured plasma concentration of LNG and EE (Cmax)

  4. Time to maximum measured plasma concentration (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)

  5. Final time taken for plasma concentration to be reduced by half (t1/2) [ 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)

  6. Final time taken for plasma concentration 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)

  7. 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 area under the plasma concentration of LNG and EE vs. time curve (AUC)

  8. 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)

  9. The first-order final elimination rate constant of EE and LNG [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    The first-order final elimination rate constant of EE and LNG

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Active users of hormonal contraception

    1. For combined methods, if they have recently stopped use, they must have had one normal menstrual cycle
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396730


Contacts
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Contact: Women's Health Research Unit Department of Ob/Gyn 503-494-3666 whru@ohsu.edu

Locations
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United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Women's Health Research Unit Department of OB/Gyn    503-494-3666    whru@ohsu.edu   
Contact: Shaalini Ramanadhan, MD       ramanadh@ohsu.edu   
Principal Investigator: Shaalini Ramanadhan, MD         
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
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Principal Investigator: Shaalini Ramanadhan, MD Oregon Health and Science University
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Responsible Party: Shaalini Ramanadhan, Clinical Instructor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04396730    
Other Study ID Numbers: STUDY00020906
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaalini Ramanadhan, Oregon Health and Science University:
Cannabidiol
Combined oral contraceptives
Additional relevant MeSH terms:
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Cannabidiol
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Anticonvulsants
Contraceptive Agents, Female