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Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)

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ClinicalTrials.gov Identifier: NCT04112095
Recruitment Status : Active, not recruiting
First Posted : October 2, 2019
Last Update Posted : March 2, 2021
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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 962 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS)
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : August 13, 2021
Estimated Study Completion Date : September 9, 2021

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 every day for up to 24 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 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.





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: Proportion of Active Use Study Days on which a subject reported taking the product. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: electronic diary

  3. Actual Use: Proportion of subjects who are adherent to daily dosing instructions. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: electronic diary

  4. Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product at the same time of the day. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: electronic diary


Secondary Outcome Measures :
  1. Self-Selection: Proportion of self-selection population who are inappropriate for use who make a correct decision regarding non-selection of the product. [ Time Frame: One Day ]
    Measurement tool: interview

  2. Actual Use: Proportion of Active Use Study Days on which a subject reported taking the product, accounting for appropriate mitigating behaviors. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: electronic diary

  3. Actual Use: Proportion of subjects who are adherent to daily dosing instructions, accounting for appropriate mitigating behaviors. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: electronic diary

  4. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: electronic diary

  5. Actual Use: Actual Use: Proportion of packs transitions without any missed pills between packs. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: electronic diary

  6. 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 24 Weeks ]
    Measurement tool: phone interview and electronic diary

  7. 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: Two Days ]
    Measurement tool: electronic diary

  8. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  9. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  10. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  11. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  12. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  13. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  14. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  15. 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. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview

  16. Actual Use: Number of pregnancies reported during the course of the study that occur while taking the product. [ Time Frame: Up to 24 Weeks ]
    Measurement tool: phone interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04112095


Locations
Show Show 38 study locations
Sponsors and Collaborators
HRA Pharma
Investigators
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Principal Investigator: Russ Bradford, MD, MSPH Pegus Research, Inc.
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Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT04112095    
Other Study ID Numbers: 151042-004
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Norgestrel
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs