NCT05988983

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,026

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 13, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

August 3, 2023

Last Update Submit

May 7, 2025

Conditions

ContraceptionContraception BehaviorContraceptive UsageHealth Care Utilization

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

OTC users

Participants using the oral contraceptive pill purchased over the counter

Other: Availability of OTC contraceptive pill

Rx users

Participants using the oral contraceptive pill received by a prescription

Interventions

Availability of OTC contraceptive pillOTHER

Over the counter contraceptive pill

OTC users

Eligibility Criteria

Age12 Years - 51 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals aged 12 to 51 who are obtaining the oral contraceptive pill at a pharmacy for the purposes of pregnancy prevention.

You may qualify if:

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

You may not qualify if:

  • Using the pill for non contraceptive indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Contraception BehaviorPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

May 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 13, 2025

Record last verified: 2025-04

Locations

US(1)