A Study on the Feasibility and Acceptability of Pericoital Levonorgestrel 1.5mg

October 29, 2021 updated by: Camber Collective
This study intends to build on the previous research and gather data in an actual use study / patient registry of pericoital LNG 1.5mg to understand women's acceptability of the product along with associated side effects, and monitoring for their correct and incorrect use. These findings will contribute to the discussion around the feasibility of pericoital LNG as an additional contraceptive by adding to the body of evidence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study would consist of distributing pericoital LNG 1.5mg across 75 pharmacy sites in Ghana over the course of 12 months. Recruitment will be staggered, and women will be recruited up to 9 months into the study. As such, the data collection period per participant will be at least 3 months.

Consistent with the recent WHO study (Festin et al. " A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using LNG 1.5mg" (2016)), participants will be given instructions on how to correctly use LNG 1.5mg, namely to take one pill 24 hours before or after sexual relations, and no more than 6 times per month. Contraceptive protection requires use only once per 24 hours, regardless of how many times sexual relations are had during those 24 hours.

Participants will include a broad population of women age 18-49, not currently on any long-term modern method, who do not wish to get pregnant in the following 6 months but would not consider it a serious issue if they did become pregnant. They will be asked to use LNG 1.5mg as their exclusive method of contraception for the period of the study, with the exception of condoms.

The drug used for the study is LNG 1.5mg, specifically Marie Stopes International's BK-1 pill, repackaged for the study purposes. The BK-1 pill is currently registered as an emergency contraceptive and sold in Ghana with good quality assurance procedures in place. The BK-1 emergency contraception pill is manufactured for Marie Stopes International by Acme Formulation Pvt., Limited, one of the leading drug manufacturers of India. It is registered as an emergency contraception by the Food and Drugs Authority in Ghana and assigned registration number FDA/SD.183-11710. The package will read "LNG 1.5mg for Pericoital Use - for study purposes only" and be devoid of any other branding (please see Appendix for artwork).

Data collection components with research participants include:

  1. Baseline background information about the research participants will be collected during the screening (e.g., qualifications for inclusion/ exclusion) and enrollment process
  2. Biweekly (i.e., every two weeks) phone call surveys with research participants. They will be asked 10 questions about user satisfaction, circumstances of use, and outcomes (e.g., self-reported side effects)
  3. Two extended surveys per participant to better understand participant perception of LNG 1.5mg, customer satisfaction with product and service, and future contraceptive intentions

Data collection components with pharmacies will include:

  1. Baseline data of average packs of FP products sold at the pharmacy, in order to understand the overall increase in FP methods sold over the course of the study
  2. A mystery shopping survey to check the quality of service provision and monitoring of recruitment/quality of information at each of the 75 study sites 2x during the study
  3. Register collected at pharmacy point of sale, with units sold over the course of the 12-month pilot. Note: participants will be able to go to any of the participating pharmacies during the course of the project.
  4. Pharmacists feedback surveys to understand the provision of LNG 1.5mg

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1980

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Accra, Ghana
        • Marie Stopes International Ghana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women from areas surrounding distribution sites (pharmacies)

Description

Inclusion Criteria:

  • between the age of 18-49 years, is willing to use LNG 1.5 mg tablets as her primary contraceptive method, wants to avoid pregnancy for at least the next 6 months after enrollment, is willing to accept an uncertain risk of pregnancy during the study, and understands that the risk of pregnancy on this method would be slightly higher than other methods of contraception

Exclusion Criteria:

  • women using one or more of the following contraceptive methods: daily pill, injectable, implant, sterilization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of use
Time Frame: 3-9 months
Self reported via bi-weekly survey: women are able to access and use product correctly (consistent with instructions from health care provider / pharmacist)
3-9 months
Acceptability
Time Frame: 3-9 months
Self reported via bi-weekly survey: Understand drivers behind decision-making of using pericoital LNG 1.5mg, conditions of use, and potential impact on increased mCPR and intention to use longer-term methods in the future
3-9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 3-9 months
Self reported via bi-weekly survey: self reported side effects from using product
3-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Camber Collective

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bill and Melinda Gates Foundation
Population Council
The Children's Investment Fund Foundation
Marie Stopes International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuel Kuffour, AYA Collective

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019LNG1.5mg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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