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Trial record 51 of 403 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT04058873
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Population Council
Marie Stopes International
Bill and Melinda Gates Foundation
The Children's Investment Fund Foundation
Information provided by (Responsible Party):
Camber Collective

Tracking Information
First Submitted Date August 14, 2019
First Posted Date August 16, 2019
Last Update Posted Date August 16, 2019
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2019)
  • feasibility of use [ Time Frame: 6 months ]
    Self reported via bi-weekly survey: women are able to access and use product correctly (consistent with instructions from health care provider / pharmacist)
  • acceptability [ Time Frame: 6 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 14, 2019)
side effects [ Time Frame: 6 months ]
Self reported via bi-weekly survey: self reported side effects from using product
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study on the Feasibility and Acceptability of Pericoital Levonorgestrel 1.5mg
Official Title A Study on the Feasibility and Acceptability of Pericoital Levonorgestrel 1.5mg
Brief Summary 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, 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.
Detailed Description

The study would consist of distributing pericoital LNG 1.5mg tablet across 75 pharmacy sites in Ghana over the course of 12 months. Recruitment will be staggered, and women will be recruited up to 6 months into the study. As such, the data collection period per participant will be at least 6 months per participant.

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. Weekly SMS / WhatsApp / 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 follow up face to face surveys per participant to better understand participant perception of LNG 1.5mg, customer satisfaction with product and service, and future contraceptive intentions (at month 2 and month 6)

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 every 4 to 6 weeks. This will amount to at least 6 visits per site over the 12 months of 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: a baseline survey before the training and a survey during month 8 of the study
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population women from areas surrounding distribution sites (pharmacies)
Condition Pregnancy Related
Intervention Drug: Levonorgestrel 1.5mg
Levonorgestrel 1.5mg for pericoital use
Study Groups/Cohorts Not Provided
Publications * Festin MP, Bahamondes L, Nguyen TM, Habib N, Thamkhantho M, Singh K, Gosavi A, Bartfai G, Bito T, Bahamondes MV, Kapp N. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg. Hum Reprod. 2016 Mar;31(3):530-40. doi: 10.1093/humrep/dev341. Epub 2016 Jan 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 14, 2019)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female only
Ages 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jessica Vandermark +33623277739 jessica@cambercollective.com
Listed Location Countries Ghana
Removed Location Countries  
 
Administrative Information
NCT Number NCT04058873
Other Study ID Numbers 2019LNG1.5mg
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Camber Collective
Study Sponsor Camber Collective
Collaborators
  • Population Council
  • Marie Stopes International
  • Bill and Melinda Gates Foundation
  • The Children's Investment Fund Foundation
Investigators
Principal Investigator: Saumya Ramarao, MD Population Council
Principal Investigator: Emmanuel Kuffour Population Council
PRS Account Camber Collective
Verification Date August 2019