OPTION: A Study of Oral Contraception Under Simulated OTC Conditions

• Sponsor: HRA Pharma (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03559010
• Collaborator: (none)
• Enrollment: 189
• Locations: 44
• Arm: 1
• Actual Duration (Months): 6.6
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 189 participants
• Allocation: N/A
• 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: Apr 27, 2018
• Actual Primary Completion Date: Sep 9, 2018
• Actual Study Completion Date: Nov 14, 2018

Arms and Interventions

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.; Other Names: Opill

Outcome Measures

Primary Outcome Measures

1. Self-selection [Day One]

   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.

2. Actual Use: Use of the Study Medication Every Day [Up to 16 weeks]

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

3. Actual Use: Use of the Study Medication at the Same Time of Day [Up to 16 weeks]

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

4. Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs [Up to 16 weeks]

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

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. [Up to 16 weeks]

   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

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 [Up to 16 weeks]

   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

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

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

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

6. Safety Population: Number of Pregnancies Reported During the Course of the Study [Up to 16 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HRA Pharma Investigational site	Birmingham	Alabama	United States	35215
2	HRA Pharma Investigational site	Homewood	Alabama	United States	35209
3	HRA Pharma Investigational site	McCalla	Alabama	United States	35111
4	HRA Pharma Investigational site	Tucson	Arizona	United States	85704
5	HRA Pharma Investigational site	Downey	California	United States	90241
6	HRA Pharma Investigational site	La Habra	California	United States	90631
7	HRA Pharma Investigational site	Long Beach	California	United States	90806
8	HRA Pharma Investigational site	Los Angeles	California	United States	90005
9	HRA Pharma Investigational site	Bridgeport	Connecticut	United States	06606
10	HRA Pharma Investigational site	Hartford	Connecticut	United States	61121
11	HRA Pharma Investigational site	New Haven	Connecticut	United States	65111
12	HRA Pharma Investigational site	Riverview	Florida	United States	33578
13	HRA Pharma Investigational site	Dalton	Georgia	United States	30721
14	HRA Pharma Investigational site	Griffin	Georgia	United States	30224
15	HRA Pharma Investigational site	Catonsville	Maryland	United States	21228
16	HRA Pharma Investigational site	Anoka	Minnesota	United States	55303
17	HRA Pharma Investigational site	Elk River	Minnesota	United States	55330
18	HRA Pharma Investigational site	Fridley	Minnesota	United States	55432
19	HRA Pharma Investigational Site	Saint Francis	Minnesota	United States	55070
20	HRA Pharma Investigational site	Elsberry	Missouri	United States	63343
21	HRA Pharma Investigational site	Manchester	Missouri	United States	63088
22	HRA Pharma Investigational Site	Savannah	Missouri	United States	64485
23	HRA Pharma Investigational site	Springfield	Missouri	United States	65807
24	HRA Pharma Investigational site	Monroe	New Jersey	United States	08831
25	HRA Pharma Investigational site	Albuquerque	New Mexico	United States	87104
26	HRA Pharma Investigational site	Albuquerque	New Mexico	United States	87109
27	HRA Pharma Investigational site	Albuquerque	New Mexico	United States	87110
28	HRA Pharma Investigational site	Burlington	North Carolina	United States	27215
29	HRA Pharma Investigational Site	South Charleston	Ohio	United States	45368
30	HRA Pharma Investigational site	Bethlehem	Pennsylvania	United States	18015
31	HRA Pharma Investigational site	Clarksville	Tennessee	United States	37043
32	HRA Pharma Investigational site	Cleveland	Tennessee	United States	37311
33	HRA Pharma Investigational site	Houston	Texas	United States	77008
34	HRA Pharma Investigational site	Houston	Texas	United States	77099
35	HRA Pharma Investigational site	Sherman	Texas	United States	75092
36	HRA Investigational site	Bountiful	Utah	United States	84010
37	HRA Pharma Investigational site	Mapleton	Utah	United States	84664
38	HRA Pharma Investigational site	Syracuse	Utah	United States	84075
39	HRA Pharma Investigational site	Montpelier	Virginia	United States	23192
40	HRA Pharma Investigational site	Enumclaw	Washington	United States	98022
41	HRA Pharma Investigational site	Kenmore	Washington	United States	98028
42	HRA Pharma Investigational site	Seattle	Washington	United States	98117
43	HRA Pharma Investigational site	Snohomish	Washington	United States	98290
44	HRA Pharma Investigational site	Amery	Wisconsin	United States	54001

Sponsors and Collaborators

• HRA Pharma

Investigators

• Principal Investigator: Russell Bradford, MD, MSPH, Pegus Research, Inc.

Study Documents (Full-Text)

• Study Protocol - Dec 15, 2017
• Statistical Analysis Plan - Mar 20, 2020

More Information

Publications

None provided.

• Responsible Party: HRA Pharma
• ClinicalTrials.gov Identifier: NCT03559010
• Other Study ID Numbers: 151042-001
• First Posted: Jun 15, 2018
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Pre-assignment Detail

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.

Arm/Group Title	Self Selection Population
Arm/Group Description	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
Period Title: Overall Study
STARTED	189
Purchaser Population	113
Use Phase Norgestrel 0.075 mg	109
COMPLETED	189
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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).
Overall Participants	189
Age (years) [Median (Full Range) ]
All participants	29.0
Sex: Female, Male (Count of Participants)
Female	188 99.5%
Male	1 0.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	31 16.4%
Not Hispanic or Latino	156 82.5%
Unknown or Not Reported	2 1.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	7 3.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	43 22.8%
White	117 61.9%
More than one race	16 8.5%
Unknown or Not Reported	6 3.2%
Region of Enrollment (Count of Participants)
United States	189 100%
Literacy using REALM test pr REALM Teen test (Count of Participants)
Normal Literacy	167 88.4%
Low Literacy	21 11.1%
Litercay Unknown	1 0.5%

Outcome Measures

1. Primary Outcome

Title	Self-selection
Description	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.
Time Frame	Day One

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Self Selection Population	Purchaser Population	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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	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.	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.
Measure Participants	0	0	0

2. Primary Outcome

Title	Actual Use: Use of the Study Medication Every Day
Description	Measurement tool: electronic diary Study prematurely discontinued No Actual Use primary Endpoint calculations were made
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Self Selection Population	Purchaser Population	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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	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.	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.
Measure Participants	0	0	0

3. Primary Outcome

Title	Actual Use: Use of the Study Medication at the Same Time of Day
Description	Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made.
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Self-selection Population	Purchaser Population	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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	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	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.
Measure Participants	0	0	0

4. Primary Outcome

Title	Actual Use: Use of the Study Medication Without an Extended Break or Any Break Between Packs
Description	Measurement tool: electronic diary Study prematurely discontinued No Actual Use endpoint calculations were made
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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.
Measure Participants	0

5. Secondary Outcome

Title	Actual Use: Proportion of User Population Who do Not Use Study Medication Together With Another Form of Hormone-containing Birth Control.
Description	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
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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.
Measure Participants	0

6. Secondary Outcome

Title	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
Description	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
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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.
Measure Participants	0

7. Secondary Outcome

Title	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
Description	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
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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.
Measure Participants	0

8. Secondary Outcome

Title	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.
Description	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.
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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.
Measure Participants	0

9. Secondary Outcome

Title	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
Description	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.
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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.
Measure Participants	0

10. Secondary Outcome

Title	Safety Population: Number of Pregnancies Reported During the Course of the Study
Description	Number of pregnancies reported during the course of the study Measurement tool: phone interview
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Use Phase Norgestrel 0.075 mg
Arm/Group Description	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.
Measure Participants	116
Number [participants]	1 0.5%

Adverse Events

Time Frame	up to 16 weeks
Arm/Group Title	Safety Population
Arm/Group Description	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.
All Cause Mortality
	Safety Population
	Affected / at Risk (%)	# Events
Total	0/116 (0%)
Serious Adverse Events
	Safety Population
	Affected / at Risk (%)	# Events
Total	4/116 (3.4%)
Pregnancy, puerperium and perinatal conditions
Exposure During Pregnancy	1/116 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Safety Population
	Affected / at Risk (%)	# Events
Total	28/116 (24.1%)
Nervous system disorders
Headache	3/116 (2.6%)	3
Migraine	3/116 (2.6%)	3
Reproductive system and breast disorders
Menorrhagia	8/116 (6.9%)	8
Metrorrhagia	8/116 (6.9%)	8
Skin and subcutaneous tissue disorders
Acne	6/116 (5.2%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.