The Over The Counter Pill National Study

NCT ID: NCT05988983

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1026 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception Contraception Behavior Contraceptive Usage Health Care Utilization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OTC users

Participants using the oral contraceptive pill purchased over the counter

Availability of OTC contraceptive pill

Intervention Type OTHER

Over the counter contraceptive pill

Rx users

Participants using the oral contraceptive pill received by a prescription

No interventions assigned to this group

Interventions

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Availability of OTC contraceptive pill

Over the counter contraceptive pill

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Capable of pregnancy
* Purchasing oral contraception at a participating pharmacy

Exclusion Criteria

* Using the pill for non contraceptive indications
Minimum Eligible Age

12 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arnold Ventures

UNKNOWN

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Maria Rodriguez, MD, MPH

Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU IRB 25984

Identifier Type: -

Identifier Source: org_study_id

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