| 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. | The clinical trial was terminated before data are collected. No Endpoints calculations were made | Posted | | | | | | Day One | | | | ID | Title | Description |
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| OG000 | Self Selection Population | 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 | | OG001 | Purchaser Population | During the face-to-face enrollment visit, potential subjects who met the inclusion and exclusion criteria for the study were given an (empty) Opill® package and were administered the enrollment interview, which comprised (1) review of the packaging, (2) determining if the product was OK or not OK for them to use and if they would like to purchase it, (3) providing limited medical history, current medication use and demographic information, (4) assessment of literacy/reading ability, (5) informed consent, (6) enrollment pregnancy test, and (7) purchase (pharmacy sites) or dispensing (clinic sites) of the Investigational Product. | | OG002 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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| 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 | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Self Selection Population | 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 | | OG001 | Purchaser Population | During the face-to-face enrollment visit, potential subjects who met the inclusion and exclusion criteria for the study were given an (empty) Opill® package and were administered the enrollment interview, which comprised (1) review of the packaging, (2) determining if the product was OK or not OK for them to use and if they would like to purchase it, (3) providing limited medical history, current medication use and demographic information, (4) assessment of literacy/reading ability, (5) informed consent, (6) enrollment pregnancy test, and (7) purchase (pharmacy sites) or dispensing (clinic sites) of the Investigational Product. | | OG002 | Use Phase Norgestrel 0.075 mg |
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| 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. | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Self-selection Population | 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 | | OG001 | Purchaser Population | During the face-to-face enrollment visit, potential subjects who met the inclusion and exclusion criteria for the study were given an (empty) Opill® package and were administered the enrollment interview, which comprised (1) review of the packaging, (2) determining if the product was OK or not OK for them to use and if they would like to purchase it, (3) providing limited medical history, current medication use and demographic information, (4) assessment of literacy/reading ability, (5) informed consent, (6) enrollment pregnancy test, and (7) purchase (pharmacy sites) or dispensing (clinic sites) of the Investigational Product | | OG002 | Use Phase Norgestrel 0.075 mg |
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| 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 | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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| 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 | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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| 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 | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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| 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 | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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| 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. | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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| 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. | the clinical trial was terminated before data are collected. No endpoints calculations were made. | Posted | | | | | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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| 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 | 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. | Posted | | Number | | participants | | Up to 16 weeks | | | | ID | Title | Description |
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| OG000 | Use Phase Norgestrel 0.075 mg | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks 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 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. |
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