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A Study of Oral Contraception Under Simulated OTC Conditions (OPTION)

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ClinicalTrials.gov Identifier: NCT03559010
Recruitment Status : Active, not recruiting
First Posted : June 15, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Norgestrel 0.075 mg tablets Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
Drug Information available for: Norgestrel

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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

  2. Actual Use: Use of the study medication every day [ Time Frame: Up to 16 weeks ]
    Measurement tool: electronic diary

  3. Actual Use: Use of the study medication at the same time of day [ Time Frame: Up to 16 weeks ]
    Measurement tool: electronic diary

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Actual Use: Number of pregnancies reported during the course of the study [ Time Frame: Up to 16 weeks ]
    Measurement tool: phone interview



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-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

Exclusion Criteria:

  • Cannot read, speak and understand English
  • Cannot see well enough to read information on the label

Information from the National Library of Medicine

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


  Show 44 Study Locations
Sponsors and Collaborators
HRA Pharma
Investigators
Principal Investigator: Russell Bradford, MD, MSPH Pegus Research, Inc.

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT03559010     History of Changes
Other Study ID Numbers: 151042-001
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by HRA Pharma:
Daily birth control

Additional relevant MeSH terms:
Norgestrel
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs