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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04112095
Other study ID # 151042-004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 6, 2019
Est. completion date August 5, 2021

Study information

Verified date May 2022
Source HRA Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 962
Est. completion date August 5, 2021
Est. primary completion date August 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Cannot read, speak and understand English - Cannot see well enough to read information on the label

Study Design


Related Conditions & MeSH terms


Intervention

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 24 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.

Locations

Country Name City State
United States HRA Pharma Investigational Site 1007 Albuquerque New Mexico
United States HRA Pharma Investigational Site 1009 Albuquerque New Mexico
United States HRA Pharma Investigational Site 1011 Andover Minnesota
United States HRA Pharma Investigational Site 1033 Aurora Colorado
United States HRA Pharma Investigational site 1012 Birmingham Alabama
United States HRA Pharma Investigational Site 1031 Bronx New York
United States HRA Pharma Investigational Site 1037 Bronx New York
United States HRA Pharma Investigational Site 1030 Bronxville New York
United States HRA Pharma Investigational Site 1015 Burlington North Carolina
United States HRA Pharma Investigational Site 1027 Cerritos California
United States HRA Pharma investigational site 1016 Clarksville Tennessee
United States HRA Pharma Investigational Site 1023 Dalton Georgia
United States HRA Pharma Investigational Site 1039 Downey California
United States HRA Pharma Investigational Site 1006 Elk River Minnesota
United States HRA Pharma Investigational Site 1021 Enumclaw Washington
United States HRA Pharma Investigational Site 1019 Framingham Massachusetts
United States HRA Pharma Investigational Site 1018 Griffin Georgia
United States HRA Pharma Investigational Site 1008 Homewood Alabama
United States HRA Pharma Investigational Site 1001 Houston Texas
United States HRA Pharma Investigational Site 1022 Houston Texas
United States HRA Pharma Investigational Site 1036 Lafayette Hill Pennsylvania
United States HRA Pharma Investigational Site 1017 Long Beach California
United States HRA Pharma investigational site 1035 Long Beach California
United States HRA Pharma Investigational Site 1028 Los Angeles California
United States HRA Pharma Investigational Site 1029 Los Angeles California
United States HRA Pharma Investigational Site 1034 Los Angeles California
United States HRA Pharma investigational site 1024 Mapleton Utah
United States HRA Pharma Investigational Site 1038 Mesa Arizona
United States HRA Pharma Investigational Site 1013 New York New York
United States HRA Pharma Investigational Site 1025 Philadelphia Pennsylvania
United States HRA Pharma Investigational Site 1032 Phoenix Arizona
United States HRA Pharma Investigational Site 1014 Rosedale Maryland
United States HRA Pharma Investigational Site 1003 Saint Francis Minnesota
United States HRA Pharma Investigational Site 1020 Saint Louis Park Minnesota
United States HRA Pharma Investigational Site 1040 Salt Lake City Utah
United States HRA Pharma Investigational site 1005 Seattle Washington
United States HRA Pharma Investigational site 1010 Snohomish Washington
United States HRA Pharma Investigational Site 1002 South Charleston Ohio

Sponsors (1)

Lead Sponsor Collaborator
HRA Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Selection: Proportion of self-selection population who make a correct selection decision regarding use of the product. Measurement tool: interview One Day
Primary Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product. Measurement tool: electronic diary Up to 24 Weeks
Primary Actual Use: Proportion of subjects who are adherent to daily dosing instructions. Measurement tool: electronic diary Up to 24 Weeks
Primary Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day. Measurement tool: electronic diary Up to 24 Weeks
Secondary Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product. Measurement tool: interview One Day
Secondary Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors. Measurement tool: electronic diary Up to 24 Weeks
Secondary Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors. Measurement tool: electronic diary Up to 24 Weeks
Secondary 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. Measurement tool: electronic diary Up to 24 Weeks
Secondary Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs. Measurement tool: electronic diary Up to 24 Weeks
Secondary Actual Use: Proportion of user population who do not use study medication together with another form of hormone containing birth control. Measurement tool: phone interview and electronic diary Up to 24 Weeks
Secondary 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. Measurement tool: electronic diary Two Days
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary 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. Measurement tool: phone interview Up to 24 Weeks
Secondary Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product. Measurement tool: phone interview Up to 24 Weeks
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