ContraceptionPhase 3OPTIONNCT03559010
A Study of Oral Contraception Under Simulated OTC Conditions
A Phase 3 study testing Norgestrel 0.075 mg tablets in people with Contraception, run by HRA Pharma at 44 sites in United States.
Trial summary
This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting. Read more about this study
- Who is it for?
- Ages 12 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Norgestrel 0.075 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 44 sitesUnited States
- Study dates
- 27 Apr 2018to 14 Nov 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -Women who are willing purchase (in the pharmacies) or be provided (in the clinics) oral contraception for their own use for the purposes of the study
Who cannot join
- Cannot read, speak and understand English
- Cannot see well enough to read information on the label
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
HRA Pharma Investigational site
Albuquerque, New Mexico, 87104
HRA Pharma Investigational site
Albuquerque, New Mexico, 87109
HRA Pharma Investigational site
Albuquerque, New Mexico, 87110
HRA Pharma Investigational site
Amery, Wisconsin, 54001
HRA Pharma Investigational site
Anoka, Minnesota, 55303
HRA Pharma Investigational site
Bethlehem, Pennsylvania, 18015
HRA Pharma Investigational site
Birmingham, Alabama, 35215
HRA Investigational site
Bountiful, Utah, 84010
HRA Pharma Investigational site
Bridgeport, Connecticut, 06606
HRA Pharma Investigational site
Burlington, North Carolina, 27215
HRA Pharma Investigational site
Catonsville, Maryland, 21228
HRA Pharma Investigational site
Clarksville, Tennessee, 37043
HRA Pharma Investigational site
Cleveland, Tennessee, 37311
HRA Pharma Investigational site
Dalton, Georgia, 30721
HRA Pharma Investigational site
Downey, California, 90241
HRA Pharma Investigational site
Elk River, Minnesota, 55330
HRA Pharma Investigational site
Elsberry, Missouri, 63343
HRA Pharma Investigational site
Enumclaw, Washington, 98022
HRA Pharma Investigational site
Fridley, Minnesota, 55432
HRA Pharma Investigational site
Griffin, Georgia, 30224
HRA Pharma Investigational site
Hartford, Connecticut, 61121
HRA Pharma Investigational site
Homewood, Alabama, 35209
HRA Pharma Investigational site
Houston, Texas, 77008
HRA Pharma Investigational site
Houston, Texas, 77099
HRA Pharma Investigational site
Kenmore, Washington, 98028
HRA Pharma Investigational site
La Habra, California, 90631
HRA Pharma Investigational site
Long Beach, California, 90806
HRA Pharma Investigational site
Los Angeles, California, 90005
HRA Pharma Investigational site
Manchester, Missouri, 63088
HRA Pharma Investigational site
Mapleton, Utah, 84664
HRA Pharma Investigational site
McCalla, Alabama, 35111
HRA Pharma Investigational site
Monroe, New Jersey, 08831
HRA Pharma Investigational site
Montpelier, Virginia, 23192
HRA Pharma Investigational site
New Haven, Connecticut, 65111
HRA Pharma Investigational site
Riverview, Florida, 33578
HRA Pharma Investigational Site
Saint Francis, Minnesota, 55070
HRA Pharma Investigational Site
Savannah, Missouri, 64485
HRA Pharma Investigational site
Seattle, Washington, 98117
HRA Pharma Investigational site
Sherman, Texas, 75092
HRA Pharma Investigational site
Snohomish, Washington, 98290
HRA Pharma Investigational Site
South Charleston, Ohio, 45368
HRA Pharma Investigational site
Springfield, Missouri, 65807
HRA Pharma Investigational site
Syracuse, Utah, 84075
HRA Pharma Investigational site
Tucson, Arizona, 85704
About this study
Official title: A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)
This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting.
Read the detailed description
Subjects will be primarily recruited via passive recruiting methods, such as in-store posters, direct mail postcards, and digital space advertising.
Respondents to advertisements will either call Clinical Research Organization (CRO) call center or visit the study website for initial screening (during which data regarding age, gender, and minimal study exclusion criteria will be collected) and scheduling of an in-person enrollment visit at a local participating research site.
During the face-to-face enrollment visit, potential subjects who meet the inclusion and exclusion criteria for the study will be given an (empty) study medication package and will be allowed as much time as they need to review the information on the outside of the entire package. Subjects will then be asked if the product is OK or not OK for them to use.
Qualified subjects then will be allowed to purchase (pharmacy sites) or be given (clinic sites) the study product.
Approximately 47 sites will be used, comprising retail pharmacy research sites and women's health clinics or adolescents' clinics.
- Conditions
- Contraception
- Being tested
- Norgestrel 0.075 mg tablets
- Keywords
- Daily birth control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norgestrel 0.075 mg tabletsDrug
Also called Opill
All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.
Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet.
| Study group | Role | What they receive |
|---|---|---|
| Use Phase Norgestrel 0.075 mg | Experimental | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks Receives: Drug: Norgestrel 0.075 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-selection
Proportion of self-selection population who make a correct selection decision regarding use of the product Study prematuraly discontinued No Self-selection endpoint calculations were made.
Measured: Day One
Actual Use: Use of the Study Medication Every Day
Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made
Measured: Up to 16 weeks
Actual Use: Use of the Study Medication at the Same Time of Day
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made.
Measured: Up to 16 weeks
Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
Measured: Up to 16 weeks
Secondary outcomes (6)
Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control.
Proportion of user population who do not use study medication together with another form of hormone-containing birth control.
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
Measured: Up to 16 weeks
Actual Use: Proportion of User Population Who Report Using a Barrier Method of Contraception (or Abstaining From Intercourse) for the First 48 Hours After Starting to Use the Study Medication
Proportion of user population who report using a barrier method of contraception (or abstaining from intercourse) for the first 48 hours after starting to use the study medication Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
Measured: Up to 16 weeks
Proportion of Self-selection Population Taking One of the "Ask a Doctor or Pharmacist Before Use" Products Who do Not Select, Who Select But do Not Use, or Who Report Contacting a Healthcare Provider or Pharmacist About Use of the Product
Proportion of self-selection population taking one of the "ask a doctor or pharmacist before use" products who do not select, who select but do not use, or who report contacting a healthcare provider Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made
Measured: Up to 16 weeks
Proportion of Self-selection Population Who Report Having Liver Problems Who Either do Not Select ,Who Select But do Not Use, or Who Report Contacting a Healthcare Provider About Use of the Product.
Proportion of self-selection population who report having liver problems who either do not select ,who select but do not use, or who report contacting a healthcare provider about use of the product.
Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made.
Measured: Up to 16 weeks
Proportion of User Population Who Experience One of the "Talk to a Doctor" Conditions Listed Within the "When Using This Product" or "Stop Use and Ask a Doctor" Sections
Proportion of user population who experience one of the "Talk to a doctor" conditions listed within the "When using this product" or "Stop use and ask a doctor" sections Measurement tool: phone interview Study prematurely discontinued No User endpoint calculations were made.
Measured: Up to 16 weeks
Safety Population: Number of Pregnancies Reported During the Course of the Study
Number of pregnancies reported during the course of the study Measurement tool: phone interview
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start27 Apr 2018
- Primary completion9 Sep 2018
- Study completion14 Nov 2018
Why it stopped: Terminated prematurely due to issues with one of the data collection systems, no impact on subject safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Bradford, MD, MSPH, Principal investigator, Pegus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559010
- Sponsor's protocol ID
- 151042-001
- Acronym
- OPTION
- Status last verified
- Mar 2022
- First submitted
- 18 May 2018
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)
- ClinicalTrials.gov ID
- NCT03559010
- Acronym / sponsor ID
- OPTION / 151042-001
- Conditions
- Contraception
- Keywords
- Daily birth control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated prematurely due to issues with one of the data collection systems, no impact on subject safety
- Enrolment
- 189 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting.
Detailed description
Subjects will be primarily recruited via passive recruiting methods, such as in-store posters, direct mail postcards, and digital space advertising.
Respondents to advertisements will either call Clinical Research Organization (CRO) call center or visit the study website for initial screening (during which data regarding age, gender, and minimal study exclusion criteria will be collected) and scheduling of an in-person enrollment visit at a local participating research site.
During the face-to-face enrollment visit, potential subjects who meet the inclusion and exclusion criteria for the study will be given an (empty) study medication package and will be allowed as much time as they need to review the information on the outside of the entire package. Subjects will then be asked if the product is OK or not OK for them to use.
Qualified subjects then will be allowed to purchase (pharmacy sites) or be given (clinic sites) the study product.
Approximately 47 sites will be used, comprising retail pharmacy research sites and women's health clinics or adolescents' clinics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use Phase Norgestrel 0.075 mg | Experimental | Drug: Norgestrel 0.075 mg tabletsNorgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Women who are willing purchase (in the pharmacies) or be provided (in the clinics) oral contraception for their own use for the purposes of the study
Key exclusion criteria (2 listed)
- Cannot read, speak and understand English
- Cannot see well enough to read information on the label
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 |
|---|---|---|
| Norgestrel 0.075 mg tabletsAlso: OpillAll subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks. Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet. | Drug | Use Phase Norgestrel 0.075 mg |
Primary outcome
Self-selection
Time frame: Day One
Proportion of self-selection population who make a correct selection decision regarding use of the product Study prematuraly discontinued No Self-selection endpoint calculations were made.
Actual Use: Use of the Study Medication Every Day
Time frame: Up to 16 weeks
Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made
Actual Use: Use of the Study Medication at the Same Time of Day
Time frame: Up to 16 weeks
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made.
Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs
Time frame: Up to 16 weeks
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
6 secondary outcomes
Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control.
Time frame: Up to 16 weeks
Actual Use: Proportion of User Population Who Report Using a Barrier Method of Contraception (or Abstaining From Intercourse) for the First 48 Hours After Starting to Use the Study Medication
Time frame: Up to 16 weeks
Proportion of Self-selection Population Taking One of the "Ask a Doctor or Pharmacist Before Use" Products Who do Not Select, Who Select But do Not Use, or Who Report Contacting a Healthcare Provider or Pharmacist About Use of the Product
Time frame: Up to 16 weeks
Proportion of Self-selection Population Who Report Having Liver Problems Who Either do Not Select ,Who Select But do Not Use, or Who Report Contacting a Healthcare Provider About Use of the Product.
Time frame: Up to 16 weeks
Proportion of User Population Who Experience One of the "Talk to a Doctor" Conditions Listed Within the "When Using This Product" or "Stop Use and Ask a Doctor" Sections
Time frame: Up to 16 weeks
Safety Population: Number of Pregnancies Reported During the Course of the Study
Time frame: Up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Russell Bradford, MD, MSPH principal investigator
Pegus Research, Inc.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Norgestrel 0.075 mg tablets in people with Contraception, run by HRA Pharma at 44 sites 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-selection (time frame: Day One). The study lists 4 primary outcomes in all. 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 4 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.