Last updated: July 7, 2023
Sponsor: Oregon Health and Science University
Overall Status: Completed
Phase
4
Condition
Contraception
Treatment
Combined oral contraceptive pill
Placebo
Cannabidiol Oil
Clinical Study ID
NCT04396730
STUDY00020906
Ages 18-35 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Have regular menses (every 21-35 days)
- Not at risk for pregnancy (not sexually active, using a barrier method of birthcontrol, using a copper IUD for birth control, have a partner with a vasectomy, havehad a tubal ligation, or in a same sex relationship)
- Generally healthy women between the age of 18 to 35 years old
- English speaking
Exclusion
Exclusion Criteria:
- Active users of hormonal contraception
- For combined methods, if they have recently stopped use, they must have had onenormal menstrual cycle
- For prior Depo-Medroxyprogesterone Acetate users, they must be off of themedication 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 beconsidered 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 OvarianSyndrome
- Impaired liver or renal function
- Smoking/vaping/e-cigarettes
- Prior bariatric surgery
- Decisional impairment
- Incarceration
Study Design
Total Participants: 9
Treatment Group(s): 3
Primary Treatment: Combined oral contraceptive pill
Phase: 4
Study Start date:
April 08, 2020
Estimated Completion Date:
March 02, 2022
Study Description
Connect with a study center
OHSU
Portland, Oregon 97239
United StatesSite Not Available
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