The Over The Counter Pill National Study | NCT05988983

Studies
The Over The Counter Pill National Study

NCT05988983

Sponsor

Oregon Health and Science University

Status

Active, not recruiting

Last Update Posted

May 13, 2025Actual

Enrollment

1,026Actual

Phase

Not provided

Conditions

Contraception
Contraception Behavior
Contraceptive Usage
Health Care Utilization

Interventions

Availability of OTC contraceptive pill

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Mar 2026Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Aug 3, 2023

First Submission Date that Met QC Criteria

Aug 3, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2025

Last Update Posted Date

May 13, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Rodriguez, MD, MPH, Professor of Obstetrics and Gynecology, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Name	Class
Arnold Ventures	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,026Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Availability of OTC contraceptive pill	Other	Over the counter contraceptive pill	OTC users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable of pregnancy
Purchasing oral contraception at a participating pharmacy

Exclusion Criteria:

Using the pill for non contraceptive indications

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

51 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003268	Contraception Behavior
D010342	Patient Acceptance of Health Care

Ancestor Terms

ID	Term
D043762	Reproductive Behavior
D001519	Behavior
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

Browse Leaves

Not provided

Browse Branches

Not provided