ContraceptionNCT05988983
The Over The Counter Pill National Study
An observational study of Contraception and Contraception Behavior, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Contraception Behavior, Contraceptive Usage
- What is being tested?
- Availability of OTC contraceptive pill
- Type of treatment
- Pill or oral medicine
- How many people
- 1,026 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 51 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals aged 12 to 51 who are obtaining the oral contraceptive pill at a pharmacy for the purposes of pregnancy prevention.
Who may be able to join
- Capable of pregnancy
- Purchasing oral contraception at a participating pharmacy
Who cannot join
- Using the pill for non contraceptive indications
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
- Being tested
- Availability of OTC contraceptive pill
- Medical subject headings
- Contraception Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Availability of OTC contraceptive pillOther
Over the counter contraceptive pill
| Study group | Role | What they receive |
|---|---|---|
| OTC users | Participants using the oral contraceptive pill purchased over the counter Receives: Other: Availability of OTC contraceptive pill | |
| Rx users | Participants using the oral contraceptive pill received by a prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month contraceptive continuation rates
Difference in proportion of participants using contraception 12 months after starting between over the counter and prescription groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 May 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Arnold Ventures
- Responsible party
- Principal investigator, Maria Rodriguez, MD, MPH, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988983
- Sponsor's protocol ID
- OHSU IRB 25984
- Status last verified
- Apr 2025
- First submitted
- 3 Aug 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Over The Counter Pill National Study
- ClinicalTrials.gov ID
- NCT05988983
- Acronym / sponsor ID
- OHSU IRB 25984
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,026 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Arnold Ventures
- Study start
- 1 May 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTC users | – | Other: Availability of OTC contraceptive pillParticipants using the oral contraceptive pill purchased over the counter |
| Rx users | – | –Participants using the oral contraceptive pill received by a prescription |
Who may qualify
- Ages
- 12 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals aged 12 to 51 who are obtaining the oral contraceptive pill at a pharmacy for the purposes of pregnancy prevention.
Key inclusion criteria (2 listed)
- Capable of pregnancy
- Purchasing oral contraception at a participating pharmacy
Key exclusion criteria (1 listed)
- Using the pill for non contraceptive indications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Availability of OTC contraceptive pillOver the counter contraceptive pill | Other | OTC users |
Primary outcome
12 month contraceptive continuation rates
Time frame: 12 months
Difference in proportion of participants using contraception 12 months after starting between over the counter and prescription groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Contraception Behavior, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 month contraceptive continuation rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.