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

NCT04058873 | Completed

• 1 other identifier: 2019LNG1.5mg
• Study Type: observational
• Target: 1,980
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• Feasibility of use

  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

  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 Outcomes (1)

• Side effects

  3-9 months

Interventions

Levonorgestrel 1.5mg DRUG

Levonorgestrel 1.5mg for pericoital use

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women from areas surrounding distribution sites (pharmacies)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Camber Collective: lead
• Population Council: collaborator
• Marie Stopes International: collaborator
• Bill and Melinda Gates Foundation: collaborator
• The Children's Investment Fund Foundation: collaborator

Study Sites (1)

Marie Stopes International Ghana

Accra, Ghana

Location

Related Publications (1)

• 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.

  PMID: 26830816 RESULT

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Emmanuel Kuffour

  AYA Collective

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 5, 2021

Record last verified: 2021-10

Locations

GH (1)