MedPath

Levonorgestrel

Generic Name
Levonorgestrel
Brand Names
Afirmelle 28 Day, Aftera, Alesse, Altavera 28 Day, Amethia 91 Day, Amethyst, Ashlyna 91 Day, Aubra 28 Day, Aviane 28, Ayuna 28 Day Pack, Balcoltra 28 Day, Bionafem, Camrese 91 Day, Camreselo 91 Day, Chateal 28 Day, Climara Pro, Curae, Daysee 91 Day, Delyla 28 Day, Dolishale 28 Day, Econtra, Enpresse 28 Day, Fallback Solo, Falmina 28 Day, Fayosim 91 Day, Her Style, Iclevia 91 Day, Indayo, Introvale 91 Day, Jaimiess 91 Day, Jolessa 91 Day, Joyeaux 28 Day, Kurvelo, Kyleena, Larissia 28 Day Pack, Levonest 28 Day, Levora 0.15/30 28 Day, Liletta, Lillow 28 Day, Lo Simpesse, LoJaimiess, Loseasonique, Lutera 28 Day, Marlissa 28 Day, Min-ovral, Mirena, Morning After, My Choice, My Way, Myzilra 28 Day, New Day, Next Choice, Next Choice One Dose, Opcicon One-step, Option 2, Orsythia 28 Day, Plan B, Plan B One-step, Portia 28 Day, Preventeza, Quartette 91 Day Pack, React, Rivelsa 91 Day, Seasonale, Seasonique, Setlakin 91 Day, Simpesse, Skyla, Sronyx 28 Day, Take Action, Triquilar, Trivora 28 Day, Twirla 3 Count Weekly Patch, Tyblume 28 Day, Vienva 28 Day
Drug Type
Small Molecule
Chemical Formula
C21H28O2
CAS Number
797-63-7
Unique Ingredient Identifier
5W7SIA7YZW

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
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
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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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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