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| Name | Class |
|---|---|
| Population Council | OTHER |
| Marie Stopes International | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
| The Children's Investment Fund Foundation |
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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.
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:
Data collection components with pharmacies will include:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel 1.5mg | Drug | Levonorgestrel 1.5mg for pericoital use |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Self reported via bi-weekly survey: self reported side effects from using product | 3-9 months |
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Inclusion Criteria:
Exclusion Criteria:
Female only
women from areas surrounding distribution sites (pharmacies)
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Kuffour | AYA Collective | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marie Stopes International Ghana | Accra | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26830816 | Result | 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. |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| OTHER |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |