Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 962
- 试验地点
- 38
- 主要终点
- Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product.
研究概览
简要总结
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.
详细描述
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 the study phone line or visit the study website for prescreening 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 obtain (pharmacy sites) or be given (clinic sites) the study product.
Approximately 35 sites will be used, comprising retail pharmacy research sites and women's health clinics or adolescents' clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are willing to purchase (in the pharmacies) or be provided (in the clinics, for women younger than 18 years old) oral contraception for their own use for the purposes of the study
排除标准
- •Cannot read, speak and understand English
- •Cannot see well enough to read information on the label
研究组 & 干预措施
Use Phase Norgestrel 0.075 mg
Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time every day for up to 24 weeks
干预措施: Norgestrel 0.075 mg tablets (Drug)
结局指标
主要结局
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product.
时间窗: Up to 24 Weeks
Measurement tool: electronic diary
Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day.
时间窗: Up to 24 Weeks
Measurement tool: electronic diary
Self-Selection: Proportion of self-selection population who make a correct selection decision regarding use of the product.
时间窗: One Day
Measurement tool: interview
Actual Use: Proportion of subjects who are adherent to daily dosing instructions.
时间窗: Up to 24 Weeks
Measurement tool: electronic diary
次要结局
- Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product.(One Day)
- Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors.(Up to 24 Weeks)
- Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors.(Up to 24 Weeks)
- Actual Use: Proportion of user population who develop sudden or severe pain in their lower belly during the course of the study who report seeking healthcare as directed by the label.(Up to 24 Weeks)
- Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product within 27 hours of the previous dose, accounting for appropriate mitigating behaviors.(Up to 24 Weeks)
- Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs.(Up to 24 Weeks)
- Actual Use: Proportion of user population who start having migraines with aura or whose migraines get worse during the course of the study who report seeking healthcare as directed by the label or who stop use.(Up to 24 Weeks)
- Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product.(Up to 24 Weeks)
- Actual Use: Proportion of user population who do not use study medication together with another form of hormone containing birth control.(Up to 24 Weeks)
- 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.(Two Days)
- Self-Select/Use: Proportion of self-select population taking products listed in the "ask a doctor or pharmacist before use" section of the label who do not select, who select but do not use, or who report contacting a HCP on product use.(Up to 24 Weeks)
- Actual Use: Proportion of user population who become pregnant during the course of the study who report stopping use and seeking healthcare as directed by the label.(Up to 24 Weeks)
- Use: Proportion of users having a late period after missing any pills in the last month, not having a period for 2 months during the course of the study who report doing a pregnancy test or seeking healthcare as directed by the label or who stop use.(Up to 24 Weeks)
- Actual Use: Proportion of user population who experience periods that last more than 8 days or are unusually heavy during the course of the study who report seeking healthcare as directed by the label or who stop use.(Up to 24 Weeks)
- Actual Use: Proportion of user population who experience repeated vaginal bleeding brought on by sex during the course of the study who report seeking healthcare as directed by the label or who stop use.(Up to 24 Weeks)
- Actual Use: Proportion of user population who develop yellowing of the skin or whites of the eyes during the course of the study who report seeking healthcare as directed by the label.(Up to 24 Weeks)