NCT03559010|TerminatedPhase 3ResultsFDA Drug

Study Stopped

Terminated prematurely due to issues with one of the data collection systems, no impact on subject safety

A Study of Oral Contraception Under Simulated OTC Conditions

OPTION

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

HRA Pharma ClinicalTrials.gov

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1 other identifier

151042-001

Study Type

interventional

Target

189

Locations

1 country

Sites

Timeline

RegisteredJun 2018

StartedApr 2018

CompletionNov 2018

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

189

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Apr 2018

Shorter than P25 for phase_3

Geographic Reach

1 country

44 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

April 27, 2018

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2018

Completed

28 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2018

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed

3.4 years until next milestone

Results Posted

Study results publicly available

April 4, 2022

Completed

Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

May 18, 2018

Results QC Date

September 15, 2021

Last Update Submit

March 30, 2022

Conditions

Contraception

Keywords

Daily birth control

Outcome Measures

Primary Outcomes (4)

Self-selection
Proportion of self-selection population who make a correct selection decision regarding use of the product Study prematuraly discontinued No Self-selection endpoint calculations were made.
Day One
Actual Use: Use of the Study Medication Every Day
Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made
Up to 16 weeks
Actual Use: Use of the Study Medication at the Same Time of Day
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made.
Up to 16 weeks
Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs
Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
Up to 16 weeks

Secondary Outcomes (6)

Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control.
Up to 16 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
Up to 16 weeks
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
Up to 16 weeks
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.
Up to 16 weeks
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
Up to 16 weeks
+1 more secondary outcomes

Study Arms (1)

Use Phase Norgestrel 0.075 mg

EXPERIMENTAL

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

Interventions

Norgestrel 0.075 mg tabletsDRUG

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.

Also known as: Opill

Use Phase Norgestrel 0.075 mg

Eligibility Criteria

Age12 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.