NCT03559010

A Study of Oral Contraception Under Simulated OTC Conditions

A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: HRA Pharma · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception

Interventions

Type	Name	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 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.

Timeline

• Start date: 2018-04-27
• Primary completion: 2018-09-09
• Completion: 2018-11-14
• First posted: 2018-06-15
• Last updated: 2022-04-04
• Results posted: 2022-04-04

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated drug study