ContraceptionPhase 3ACCESSNCT04112095
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
A Phase 3 study testing Norgestrel 0.075 mg tablets in people with Contraception, run by HRA Pharma at 38 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 11 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
- 962 participants
- Where
- 38 sitesUnited States
- Study dates
- 6 Sep 2019to 5 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 11 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who are willing to purchase (in the pharmacies) or be provided (in the clinics, for women younger than 18 years old) 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
38 sites in 1 country.
38 sites in 1 country
United States38 sites
HRA Pharma Investigational Site 1009
Albuquerque, New Mexico, 87104
HRA Pharma Investigational Site 1007
Albuquerque, New Mexico, 97110
HRA Pharma Investigational Site 1011
Andover, Minnesota, 55304
HRA Pharma Investigational Site 1033
Aurora, Colorado, 80045
HRA Pharma Investigational site 1012
Birmingham, Alabama, 35215
HRA Pharma Investigational Site 1030
Bronxville, New York, 10708
HRA Pharma Investigational Site 1015
Burlington, North Carolina, 27215
HRA Pharma Investigational Site 1027
Cerritos, California, 90703
HRA Pharma investigational site 1016
Clarksville, Tennessee, 37043
HRA Pharma Investigational Site 1023
Dalton, Georgia, 30721
HRA Pharma Investigational Site 1039
Downey, California, 90242
HRA Pharma Investigational Site 1006
Elk River, Minnesota, 55330
HRA Pharma Investigational Site 1021
Enumclaw, Washington, 98022
HRA Pharma Investigational Site 1019
Framingham, Massachusetts, 01702
HRA Pharma Investigational Site 1018
Griffin, Georgia, 30224
HRA Pharma Investigational Site 1008
Homewood, Alabama, 35209
HRA Pharma Investigational Site 1022
Houston, Texas, 77008
HRA Pharma Investigational Site 1001
Houston, Texas, 77099
HRA Pharma Investigational Site 1036
Lafayette Hill, Pennsylvania, 19444
HRA Pharma investigational site 1035
Long Beach, California, 90806
HRA Pharma Investigational Site 1017
Long Beach, California, 90815
HRA Pharma Investigational Site 1034
Los Angeles, California, 90005
HRA Pharma Investigational Site 1029
Los Angeles, California, 90036
HRA Pharma Investigational Site 1028
Los Angeles, California, 90057
HRA Pharma investigational site 1024
Mapleton, Utah, 84664
HRA Pharma Investigational Site 1038
Mesa, Arizona, 85203
HRA Pharma Investigational Site 1013
New York, New York, 10034
HRA Pharma Investigational Site 1025
Philadelphia, Pennsylvania, 19136
HRA Pharma Investigational Site 1032
Phoenix, Arizona, 85021
HRA Pharma Investigational Site 1014
Rosedale, Maryland, 21237
HRA Pharma Investigational Site 1003
Saint Francis, Minnesota, 55070
HRA Pharma Investigational Site 1020
Saint Louis Park, Minnesota, 55426
HRA Pharma Investigational Site 1040
Salt Lake City, Utah, 84101
HRA Pharma Investigational site 1005
Seattle, Washington, 98117
HRA Pharma Investigational site 1010
Snohomish, Washington, 98290
HRA Pharma Investigational Site 1002
South Charleston, Ohio, 45368
HRA Pharma Investigational Site 1037
The Bronx, New York, 10463
HRA Pharma Investigational Site 1031
The Bronx, New York, 10467
About this study
Official title: Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)
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 the study phone line or visit the study website for prescreening 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 obtain (pharmacy sites) or be given (clinic sites) the study product.
Approximately 35 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
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 24 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 every day for up to 24 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.
Measurement tool: interview
Measured: One Day
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product.
Measurement tool: electronic diary
Measured: Up to 24 Weeks
Actual Use: Proportion of subjects who are adherent to daily dosing instructions.
Measurement tool: electronic diary
Measured: Up to 24 Weeks
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day.
Measurement tool: electronic diary
Measured: Up to 24 Weeks
Secondary outcomes (16)
Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product.
Measurement tool: interview
Measured: One Day
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors.
Measurement tool: electronic diary
Measured: Up to 24 Weeks
Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors.
Measurement tool: electronic diary
Measured: Up to 24 Weeks
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product within 27 hours of the previous dose, accounting for appropriate mitigating behaviors.
Measurement tool: electronic diary
Measured: Up to 24 Weeks
Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs.
Measurement tool: electronic diary
Measured: Up to 24 Weeks
Actual Use: Proportion of user population who do not use study medication together with another form of hormone containing birth control.
Measurement tool: phone interview and electronic diary
Measured: Up to 24 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.
Measurement tool: electronic diary
Measured: Two Days
Self-Select/Use: Proportion of self-select population taking products listed in the "ask a doctor or pharmacist before use" section of the label who do not select, who select but do not use, or who report contacting a HCP on product use.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Actual Use: Proportion of user population who become pregnant during the course of the study who report stopping use and seeking healthcare as directed by the label.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Actual Use: Proportion of user population who develop sudden or severe pain in their lower belly during the course of the study who report seeking healthcare as directed by the label.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Use: Proportion of users having a late period after missing any pills in the last month, not having a period for 2 months during the course of the study who report doing a pregnancy test or seeking healthcare as directed by the label or who stop use.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Actual Use: Proportion of user population who experience periods that last more than 8 days or are unusually heavy during the course of the study who report seeking healthcare as directed by the label or who stop use.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Actual Use: Proportion of user population who experience repeated vaginal bleeding brought on by sex during the course of the study who report seeking healthcare as directed by the label or who stop use.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Actual Use: Proportion of user population who start having migraines with aura or whose migraines get worse during the course of the study who report seeking healthcare as directed by the label or who stop use.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Actual Use: Proportion of user population who develop yellowing of the skin or whites of the eyes during the course of the study who report seeking healthcare as directed by the label.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product.
Measurement tool: phone interview
Measured: Up to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start6 Sep 2019
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug: Norgestrel 0.075 mg tablets 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 24 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.
- Masking
- None (open label)
- Enrolment
- 962 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russ Bradford, MD, MSPH, Principal investigator, Pegus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112095
- Sponsor's protocol ID
- 151042-004
- Acronym
- ACCESS
- Status last verified
- May 2022
- First submitted
- 30 Sep 2019
- Last updated
- 20 May 2022
- Results posted
- No
- 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)
- ClinicalTrials.gov ID
- NCT04112095
- Acronym / sponsor ID
- ACCESS / 151042-004
- Conditions
- Contraception
- Keywords
- Daily birth control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 962 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 2 Oct 2019 (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 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 the study phone line or visit the study website for prescreening 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 obtain (pharmacy sites) or be given (clinic sites) the study product.
Approximately 35 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
- Model description
- Drug: Norgestrel 0.075 mg tablets 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 24 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.
| 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 every day for up to 24 weeks |
Who may qualify
- Ages
- 11 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women who are willing to purchase (in the pharmacies) or be provided (in the clinics, for women younger than 18 years old) 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 tabletsAll 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 24 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: Proportion of self-selection population who make a correct selection decision regarding use of the product.
Time frame: One Day
Measurement tool: interview
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product.
Time frame: Up to 24 Weeks
Measurement tool: electronic diary
Actual Use: Proportion of subjects who are adherent to daily dosing instructions.
Time frame: Up to 24 Weeks
Measurement tool: electronic diary
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day.
Time frame: Up to 24 Weeks
Measurement tool: electronic diary
16 secondary outcomes
Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product.
Time frame: One Day
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors.
Time frame: Up to 24 Weeks
Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors.
Time frame: Up to 24 Weeks
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product within 27 hours of the previous dose, accounting for appropriate mitigating behaviors.
Time frame: Up to 24 Weeks
Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs.
Time frame: Up to 24 Weeks
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 24 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: Two Days
Self-Select/Use: Proportion of self-select population taking products listed in the "ask a doctor or pharmacist before use" section of the label who do not select, who select but do not use, or who report contacting a HCP on product use.
Time frame: Up to 24 Weeks
Actual Use: Proportion of user population who become pregnant during the course of the study who report stopping use and seeking healthcare as directed by the label.
Time frame: Up to 24 Weeks
Actual Use: Proportion of user population who develop sudden or severe pain in their lower belly during the course of the study who report seeking healthcare as directed by the label.
Time frame: Up to 24 Weeks
Use: Proportion of users having a late period after missing any pills in the last month, not having a period for 2 months during the course of the study who report doing a pregnancy test or seeking healthcare as directed by the label or who stop use.
Time frame: Up to 24 Weeks
Actual Use: Proportion of user population who experience periods that last more than 8 days or are unusually heavy during the course of the study who report seeking healthcare as directed by the label or who stop use.
Time frame: Up to 24 Weeks
Actual Use: Proportion of user population who experience repeated vaginal bleeding brought on by sex during the course of the study who report seeking healthcare as directed by the label or who stop use.
Time frame: Up to 24 Weeks
Actual Use: Proportion of user population who start having migraines with aura or whose migraines get worse during the course of the study who report seeking healthcare as directed by the label or who stop use.
Time frame: Up to 24 Weeks
Actual Use: Proportion of user population who develop yellowing of the skin or whites of the eyes during the course of the study who report seeking healthcare as directed by the label.
Time frame: Up to 24 Weeks
Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product.
Time frame: Up to 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- 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.
Russ Bradford, MD, MSPH principal investigator
Pegus Research, Inc.
38 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 38 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: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Proportion of self-selection population who make a correct selection decision regarding use of the product. (time frame: One Day). 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 20 May 2022.