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NCT05988983 Clinical Trial

The Over The Counter Pill National Study

Contraception Clinical Trial

Official title:
The Over The Counter Pill National Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05988983
Other study ID # OHSU IRB 14123
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date October 1, 2025

Study information
Verified date April 2024
Source Oregon Health and Science University
Contact Maria I Rodriguez, MD
Phone 503-494-7921
Email rodrigma@ohsu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective cohort study of individuals purchasing the oral contraceptive pill over the counter (OTC) in pharmacies in 32 US states. The comparison group is people receiving a prescription (Rx) for oral contraception. Both groups will be followed for one year to examine contraceptive continuation rates. This study will also identify who is using the pill OTC and why and evaluate differences in pregnancy intention and measures of contraceptive agency between the two groups.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 900
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years to 51 Years
Eligibility Inclusion Criteria: - Capable of pregnancy - Purchasing oral contraception at a participating pharmacy Exclusion Criteria: - Using the pill for non contraceptive indications

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Availability of OTC contraceptive pill
Over the counter contraceptive pill

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Oregon Health and Science University Arnold Ventures

Outcome
Type Measure Description Time frame Safety issue
Primary 12 month contraceptive continuation rates Difference in proportion of participants using contraception 12 months after starting between over the counter and prescription groups. 12 months
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