Trial Outcomes & Findings for A Study of Oral Contraception Under Simulated OTC Conditions (NCT NCT03559010)

NCT ID: NCT03559010

Last Updated: 2022-04-04

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 189 participants
• Primary outcome timeframe: Day One
• Results posted on: 2022-04-04

Participant Flow

Self-selection population: participants who accept the invitation to participate and meet study inclusion criteria, participate in a face-to-face interview at the study site, make a self-selection decision, and provide responses to all relevant medical history questions. Purchaser Population: responders who meet study enrollment criteria and purchase/obtain the study medication. Use Phase Norgestrel 0.075 mg: subjects who take at least one dose of study medication during the study.

Participant milestones

Measure	Self Selection Population Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study
Overall Study STARTED	189
Overall Study Purchaser Population	113
Overall Study Use Phase Norgestrel 0.075 mg	109
Overall Study COMPLETED	189
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Oral Contraception Under Simulated OTC Conditions

Baseline characteristics by cohort

Measure	All Participants n=189 Participants Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study. The total number of subjects enrolled is 189. Out of the 189 subjects, 113 were included in the Purchaser population. And in 113 subjects included in Purchaser Population, 109 were in Use Phase (Users).
Age, Continuous All participants	29.0 years n=5 Participants
Sex: Female, Male All participants · Female	188 Participants n=5 Participants
Sex: Female, Male All participants · Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) All participants · Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) All participants · Not Hispanic or Latino	156 Participants n=5 Participants
Ethnicity (NIH/OMB) All participants · Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants
Race (NIH/OMB) White	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	16 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	189 Participants n=5 Participants
Literacy using REALM test pr REALM Teen test Normal Literacy	167 Participants n=5 Participants
Literacy using REALM test pr REALM Teen test Low Literacy	21 Participants n=5 Participants
Literacy using REALM test pr REALM Teen test Litercay Unknown	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day One

Population: The clinical trial was terminated before data are collected. No Endpoints calculations were made

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

Proportion of user population who do not use study medication together with another form of hormone-containing birth control.

Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

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 Study prematurely discontinued No Actual Use endpoint calculations were made

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

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 Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

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.

Measurement tool: phone interview Study prematurely discontinued No Self-selection endpoint calculations were made.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: the clinical trial was terminated before data are collected. No endpoints calculations were made.

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 Measurement tool: phone interview Study prematurely discontinued No User endpoint calculations were made.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: Arms are combined in the safety population. The safety population included 116 subjects who provided informed consent, 113 of whom purchased the IP and entered the use phase of the study.

Number of pregnancies reported during the course of the study Measurement tool: phone interview

Outcome measures

Measure	Self Selection Population n=116 Participants Males or females at least 12 years of age who presented at a pharmacy study site in response to advertising or who presented to a clinic site seeking an oral contraceptive could be enrolled in the Self-Selection population of the study	Purchaser Population During the face-to-face enrollment visit, potential subjects who met the inclusion and exclusion criteria for the study were given an (empty) Opill® package and were administered the enrollment interview, which comprised (1) review of the packaging, (2) determining if the product was OK or not OK for them to use and if they would like to purchase it, (3) providing limited medical history, current medication use and demographic information, (4) assessment of literacy/reading ability, (5) informed consent, (6) enrollment pregnancy test, and (7) purchase (pharmacy sites) or dispensing (clinic sites) of the Investigational Product.	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 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.
Safety Population: Number of Pregnancies Reported During the Course of the Study	1 participants	—	—

Adverse Events

Safety Population

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Safety Population n=116 participants at risk Arms are combined in the safety population. The safety population included 116 subjects who provided informed consent, 113 of whom purchased the IP and entered the use phase of the study.
Pregnancy, puerperium and perinatal conditions Exposure During Pregnancy	0.86% 1/116 • Number of events 1 • up to 16 weeks

Other adverse events

Measure	Safety Population n=116 participants at risk Arms are combined in the safety population. The safety population included 116 subjects who provided informed consent, 113 of whom purchased the IP and entered the use phase of the study.
Nervous system disorders Headache	2.6% 3/116 • Number of events 3 • up to 16 weeks
Nervous system disorders Migraine	2.6% 3/116 • Number of events 3 • up to 16 weeks
Skin and subcutaneous tissue disorders Acne	5.2% 6/116 • Number of events 6 • up to 16 weeks
Reproductive system and breast disorders Menorrhagia	6.9% 8/116 • Number of events 8 • up to 16 weeks
Reproductive system and breast disorders Metrorrhagia	6.9% 8/116 • Number of events 8 • up to 16 weeks

Additional Information

Christine VENARD

HRA Pharma

Phone: 33 1 84 13 92 44

Email: c.venard@hra-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place