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Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use

2019-10-08 08:47:40 | BioPortfolio

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.

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 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.

Study Design

Conditions

Contraception

Intervention

Norgestrel 0.075 mg tablets

Location

HRA Pharma Investigational site 1012
Birmingham
Alabama
United States
35215

Status

Recruiting

Source

HRA Pharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-08T08:47:40-0400

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Medical and Biotech [MESH] Definitions

A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

Methods of contraception in which physical, chemical, or biological means are used to prevent the SPERM from reaching the fertilizable OVUM.

Behavior patterns of those practicing CONTRACEPTION.

Prevention of CONCEPTION by blocking fertility temporarily, or permanently (STERILIZATION, REPRODUCTIVE). Common means of reversible contraception include NATURAL FAMILY PLANNING METHODS; CONTRACEPTIVE AGENTS; or CONTRACEPTIVE DEVICES.

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