A Study of Oral Contraception Under Simulated OTC Conditions
- Registration Number
- NCT03559010
- Lead Sponsor
- HRA Pharma
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 189
-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
- Cannot read, speak and understand English
- Cannot see well enough to read information on the label
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Use Phase Norgestrel 0.075 mg Norgestrel 0.075 mg tablets Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time everyday for up to 16 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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 madeActual 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.
Trial Locations
- Locations (3)
HRA Pharma Investigational site
🇺🇸Amery, Wisconsin, United States
HRA Investigational site
🇺🇸Bountiful, Utah, United States
HRA Pharma Investigational Site
🇺🇸South Charleston, Ohio, United States