Contraception
Conditions
Keywords
Daily birth control
Brief 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.
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.
Interventions
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.
Sponsors
HRA Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-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
Exclusion criteria
* Cannot read, speak and understand English * Cannot see well enough to read information on the label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-selection | 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 | 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 | 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 | Up to 16 weeks | Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 Measurement tool: phone interview Study prematurely discontinued No User endpoint calculations were made. |
| Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control. | Up to 16 weeks | 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 |
| Safety Population: Number of Pregnancies Reported During the Course of the Study | Up to 16 weeks | Number of pregnancies reported during the course of the study Measurement tool: phone interview |
| 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 | Up to 16 weeks | 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 |
| 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 | 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 Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made |
| 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. | 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. Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made. |
Countries
United States
Participant flow
Pre-assignment details
Self-selection population: participants who accept the invitation to participate and meet study inclusion criteria, participate in a face-to-face interview at the study site, make a self-selection decision, and provide responses to all relevant medical history questions. Purchaser Population: responders who meet study enrollment criteria and purchase/obtain the study medication. Use Phase Norgestrel 0.075 mg: subjects who take at least one dose of study medication during the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study.
The total number of subjects enrolled is 189. Out of the 189 subjects, 113 were included in the Purchaser population. And in 113 subjects included in Purchaser Population, 109 were in Use Phase (Users). | 189 |
| Total | 189 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous All participants | 29.0 years |
| Ethnicity (NIH/OMB) All participants Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) All participants Not Hispanic or Latino | 156 Participants |
| Ethnicity (NIH/OMB) All participants Unknown or Not Reported | 2 Participants |
| Literacy using REALM test pr REALM Teen test Litercay Unknown | 1 Participants |
| Literacy using REALM test pr REALM Teen test Low Literacy | 21 Participants |
| Literacy using REALM test pr REALM Teen test Normal Literacy | 167 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 117 Participants |
| Region of Enrollment United States | 189 Participants |
| Sex: Female, Male All participants Female | 188 Participants |
| Sex: Female, Male All participants Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 116 |
| other Total, other adverse events | 28 / 116 |
| serious Total, serious adverse events | 4 / 116 |
Outcome results
Primary
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.
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Primary
Actual Use: Use of the Study Medication Every Day
Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Primary
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
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Primary
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.
Time frame: Day One
Population: The clinical trial was terminated before data are collected. No Endpoints calculations were made
Secondary
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
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Secondary
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
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Secondary
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
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Secondary
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.
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Secondary
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.
Time frame: Up to 16 weeks
Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.
Secondary
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
Time frame: Up to 16 weeks
Population: Arms are combined in the safety population. The safety population included 116 subjects who provided informed consent, 113 of whom purchased the IP and entered the use phase of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self Selection Population | Safety Population: Number of Pregnancies Reported During the Course of the Study | 1 participants |