Overview
Levonorgestrel (LNG) is a synthetic progestogen similar to Progesterone used in contraception and hormone therapy. Also known as Plan B, it is used as a single agent in emergency contraception, and as a hormonal contraceptive released from an intrauterine device, commonly referred to as an IUD. Some of these devices are known as Jaydess, Kyleena, and Mirena. A subdermal implant of levonorgestrel that slowly releases the hormone over a long-term period is also available. In addition to the above uses, levonorgestrel is used as a component of long-term combination contraceptives. Globally, levonorgestrel is the most commonly used emergency contraceptive. It was initially granted FDA approval in 1982 and was the first emergency contraceptive containing only progesterone, showing high levels of efficacy and a lack of estrogenic adverse effects when compared to older emergency contraceptive regimens.
Background
Levonorgestrel (LNG) is a synthetic progestogen similar to Progesterone used in contraception and hormone therapy. Also known as Plan B, it is used as a single agent in emergency contraception, and as a hormonal contraceptive released from an intrauterine device, commonly referred to as an IUD. Some of these devices are known as Jaydess, Kyleena, and Mirena. A subdermal implant of levonorgestrel that slowly releases the hormone over a long-term period is also available. In addition to the above uses, levonorgestrel is used as a component of long-term combination contraceptives. Globally, levonorgestrel is the most commonly used emergency contraceptive. It was initially granted FDA approval in 1982 and was the first emergency contraceptive containing only progesterone, showing high levels of efficacy and a lack of estrogenic adverse effects when compared to older emergency contraceptive regimens.
Indication
Emergency contraception Levonorgestrel, in the single-agent emergency contraceptive form, is indicated for the prevention of pregnancy after the confirmed or suspected failure of contraception methods or following unprotected intercourse. It is distributed by prescription for patients under 17, and over the counter for those above this age. This levonorgestrel-only form of contraception is not indicated for regular contraception and must be taken as soon as possible within 72 hours after intercourse. It has shown a lower efficacy when it is used off label within 96 hours. Long-term contraception or nonemergency contraception In addition to the above indication in emergency contraception, levonorgestrel is combined with other contraceptives in contraceptive formulations designed for regular use, for example with ethinyl estradiol. It is used in various hormone-releasing intrauterine devices for long-term contraception ranging for a duration of 3-5 years. Product labeling for Mirena specifically mentions that it is recommended in women who have had at least 1 child and can be indicated for the prevention of pregnancy for up to 8 years. A subdermal implant is also available for the prevention of pregnancy for up to 5 years. Hormone therapy and off-label uses Levonorgestrel is prescribed in combination with estradiol as hormone therapy during menopause to manage vasomotor symptoms and to prevent osteoporosis.Off-label, levonorgestrel may be used to treat menorrhagia, endometrial hyperplasia, and endometriosis.
Associated Conditions
- Endometrial Hyperplasia
- Endometriosis
- Heavy Menstrual Bleeding
- Hypermenorrhea
- Postmenopausal Osteoporosis
- Pregnancy
- Moderate Menopausal Vasomotor Symptoms
- Severe Vasomotor Symptoms Associated With Menopause
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/08/08 | Phase 2 | UNKNOWN | KK Women's and Children's Hospital | ||
2022/07/06 | Phase 4 | Recruiting | |||
2022/03/16 | Phase 1 | Completed | |||
2021/10/26 | Phase 1 | Completed | |||
2021/09/16 | Not Applicable | Recruiting | |||
2021/06/02 | Phase 4 | Active, not recruiting | Botswana Harvard AIDS Institute Partnership | ||
2021/05/21 | Phase 3 | Withdrawn | |||
2021/05/04 | Not Applicable | Completed | |||
2021/03/24 | Phase 4 | Completed | |||
2021/03/08 | N/A | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Actavis Pharma, Inc. | 52544-295 | ORAL | 90 ug in 1 1 | 12/31/2021 | |
GAVIS Pharmaceuticals, LLC. | 43386-620 | ORAL | 1.5 mg in 1 1 | 2/27/2013 | |
Rebel Distributors Corp. | 21695-443 | ORAL | 0.75 mg in 1 1 | 7/1/2009 | |
Pharmacist Pharmaceutical, LLC | 63704-009 | ORAL | 1.5 mg in 1 1 | 7/29/2013 | |
Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 | 64122-605 | ORAL | 1.5 mg in 1 1 | 5/1/2025 | |
Allergan, Inc. | 0023-5858 | INTRAUTERINE | 52 mg in 1 1 | 10/3/2023 | |
Lupin Pharmaceuticals, Inc. | 68180-851 | ORAL | 0.75 mg in 1 1 | 1/15/2019 | |
H.J. Harkins Company, Inc. | 52959-450 | ORAL | 0.75 mg in 1 1 | 10/29/2012 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-424 | INTRAUTERINE | 19.5 mg in 1 1 | 3/1/2018 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-423 | INTRAUTERINE | 52 mg in 1 1 | 12/21/2016 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Levonorgestrel Tablets | 国药准字H19983072 | 化学药品 | 片剂 | 4/9/2020 | |
Levonorgestrel Tablets | 国药准字H20184035 | 化学药品 | 片剂 | 2/25/2023 | |
Levonorgestrel Tablets | 国药准字H20223038 | 化学药品 | 片剂 | 1/30/2022 | |
Levonorgestrel Tablets | 国药准字H20163176 | 化学药品 | 片剂 | 1/12/2024 | |
Levonorgestrel Tablets | 国药准字H20023296 | 化学药品 | 片剂 | 6/17/2020 | |
Levonorgestrel Tablets | 国药准字H20113212 | 化学药品 | 片剂 | 4/21/2021 | |
Levonorgestrel Tablets | 国药准字H20133081 | 化学药品 | 片剂 | 1/4/2023 | |
Levonorgestrel Tablets | H20140728 | 化学药品 | 片剂 | 12/6/2019 | |
Levonorgestrel Tablets | 国药准字H20184036 | 化学药品 | 片剂 | 2/25/2023 | |
Levonorgestrel Tablets | 国药准字H20093259 | 化学药品 | 片剂 | 1/12/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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