A Study of Oral Contraception Under Simulated OTC Conditions (OPTION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03559010|
Recruitment Status : Terminated (Terminated prematurely due to issues with one of the data collection systems, no impact on subject safety)
First Posted : June 15, 2018
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Norgestrel 0.075 mg tablets||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)|
|Actual Study Start Date :||April 27, 2018|
|Actual Primary Completion Date :||September 9, 2018|
|Actual Study Completion Date :||November 14, 2018|
Experimental: 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
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 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.
- 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: Use of the study medication every day [ Time Frame: Up to 16 weeks ]Measurement tool: electronic diary
- Actual Use: Use of the study medication at the same time of day [ Time Frame: Up to 16 weeks ]Measurement tool: electronic diary
- 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
- 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 ]Measurement tool: electronic diary
- 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 ]Measurement tool: electronic diary
- 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 ]Measurement tool: phone interview
- 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 ]Measurement tool: phone interview
- 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 ]Measurement tool: phone interview
- Actual Use: Number of pregnancies reported during the course of the study [ Time Frame: Up to 16 weeks ]Measurement tool: phone interview
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559010
|Principal Investigator:||Russell Bradford, MD, MSPH||Pegus Research, Inc.|