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.

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

Research Report

Published: Jul 31, 2025

Levonorgestrel (DB00367): A Comprehensive Monograph on its Chemistry, Pharmacology, Clinical Utility, and Development

Executive Summary

Levonorgestrel is a second-generation synthetic progestin that stands as a cornerstone of modern hormonal therapy and contraception. As the biologically active levorotatory enantiomer of norgestrel, it exerts potent progestational and androgenic effects, primarily by inhibiting ovulation through the suppression of the mid-cycle luteinizing hormone (LH) surge. Its remarkable versatility is demonstrated by its incorporation into a vast array of formulations, each tailored to a specific clinical need. These range from high-dose oral tablets for emergency contraception (EC) to low-dose daily oral pills (both combination and progestin-only), and long-acting reversible contraceptives (LARCs) such as subdermal implants and intrauterine devices (IUDs). Beyond contraception, levonorgestrel-releasing IUDs are approved for treating heavy menstrual bleeding and are used off-label for managing conditions like endometriosis and endometrial hyperplasia.

The pharmacological profile of levonorgestrel is well-characterized, but its clinical performance is significantly influenced by patient-specific factors, most notably body mass index (BMI). Pharmacokinetic studies have definitively shown that in women with obesity, increased volume of distribution and metabolic clearance lead to substantially lower plasma concentrations, providing a clear mechanistic basis for the observed reduction in EC efficacy in this population. This has highlighted a critical unmet need for evidence-based dosing strategies in individuals with high BMI.

Continue reading the full research report

Clinical Trials

View More Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore	2022/08/08	NCT05492487	Phase 2	UNKNOWN	KK Women's and Children's Hospital
Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start	2022/07/06	NCT05444582	Phase 4	Recruiting	University of Utah
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product	2022/03/16	NCT05282940	Phase 1	Completed	Laboratorios Andromaco S.A.
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS	2021/10/26	NCT05093205	Phase 1	Completed	Pfizer
Kuwa Free! - Live Free!	2021/09/16	NCT05044962	Not Applicable	Recruiting	University of Alabama at Birmingham
Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV	2021/06/02	NCT04910711	Phase 4	Active, not recruiting	Botswana Harvard AIDS Institute Partnership
Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia	2021/05/21	NCT04897217	Phase 3	Withdrawn	Wake Forest University Health Sciences
Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele	2021/05/04	NCT04872244	Not Applicable	Completed	Gaziosmanpasa Research and Education Hospital
Impact of Contraceptives on Cervico-Vaginal Mucosa	2021/03/24	NCT04814927	Phase 4	Completed	Eastern Virginia Medical School
The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception	2021/03/08	NCT04785950	N/A	Completed	Bayer

FDA Drug Approvals

View More FDA Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Amethyst	Actavis Pharma, Inc.	52544-295	ORAL	90 ug in 1 1	12/31/2021
My Way	GAVIS Pharmaceuticals, LLC.	43386-620	ORAL	1.5 mg in 1 1	2/27/2013
NEXT CHOICE	Rebel Distributors Corp.	21695-443	ORAL	0.75 mg in 1 1	7/1/2009
Levonorgestrel	Pharmacist Pharmaceutical, LLC	63704-009	ORAL	1.5 mg in 1 1	7/29/2013
AfterPill	Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880	64122-605	ORAL	1.5 mg in 1 1	5/1/2025
LILETTA	Allergan, Inc.	0023-5858	INTRAUTERINE	52 mg in 1 1	10/3/2023
Levonorgestrel	Lupin Pharmaceuticals, Inc.	68180-851	ORAL	0.75 mg in 1 1	1/15/2019
Restart	Winx Health Inc.	80584-103	ORAL	1.5 mg in 1 1	8/27/2025
Next Choice	H.J. Harkins Company, Inc.	52959-450	ORAL	0.75 mg in 1 1	10/29/2012
Kyleena	Bayer HealthCare Pharmaceuticals Inc.	50419-424	INTRAUTERINE	19.5 mg in 1 1	3/1/2018

EMA Drug Approvals

View More EMA Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
LEVONORGESTREL-1 GH levonorgestrel 1.5mg tablet blister pack	217542	Lupin Australia Pty Limited	Medicine	A	11/20/2013
LEVONORGESTREL-1 APOTEX levonorgestrel 1.5 mg tablet blister pack	231507	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/5/2014
MICROGYNON 20 ED tablet blister pack	63484	Bayer Australia Ltd	Medicine	A	11/16/1998
FEMME-TAB 30/150 levonorgestrel 150mcg ethinylestradiol 30mcg film-coated tablet blister pack	170386	AFT Pharmaceuticals Pty Ltd	Medicine	A	1/10/2012
FEMME-TAB 20/100 levonorgestrel 100mcg ethinylestradiol 20mcg film-coated tablet blister pack	170387	AFT Pharmaceuticals Pty Ltd	Medicine	A	1/10/2012
SEASONIQUE levonorgestrel/ethinylestradiol 150 ug/30 ug film coated tablets and ethinylestradiol 10 ug film coated tablets blister composite pack	238384	Theramex Australia Pty Ltd	Medicine	A	5/24/2016
LEVONORGESTREL/ETHINYLESTRADIOL-RJIC levonorgestrel 100 microgram and ethinylestradiol 20 microgram film-coated tablet blister pack	425693	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/8/2024
LEVONELLE-1 levonorgestrel 1.5mg tablet blister pack	149270	Gedeon Richter Australia Pty Ltd	Medicine	A	1/16/2008
APOHEALTH LEVONORGESTREL levonorgestrel 1.5 mg tablet blister pack	499325	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/9/2025
FEMME TAB ED 20/100 levonorgestrel 100mcg ethinylestradiol 20mcg film-coated blister pack	170389	AFT Pharmaceuticals Pty Ltd	Medicine	A	1/10/2012

Health Canada Drug Approvals

View More Health Canada Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TRIQUILAR 21	Bayer Inc	00707600	Tablet - Oral	75 MCG	12/31/1987
TRIQUILAR 21	Bayer Inc	00707600	Tablet - Oral	50 MCG	12/31/1987
TRIQUILAR 21	Bayer Inc	00707600	Tablet - Oral	125 MCG	12/31/1987
ESME 28	Mylan Pharmaceuticals ULC	02388146	Tablet - Oral	100 MCG	7/5/2012
MIN-OVRAL 21	Pfizer Canada Ulc	02042320	Tablet - Oral	150 MCG	12/31/1995
PORTIA 28	teva canada limited	02295954	Tablet - Oral	0.15 MG	8/14/2007
NEXT CHOICE	actavis pharma company	02364905	Tablet - Oral	0.75 MG	5/13/2011
LEVONORGESTREL TABLETS, 0.75MG	LUPIN LIMITED	02431033	Tablet - Oral	0.75 MG	N/A
TRIPHASIL 21 TAB	wyeth ltd.	00782416	Tablet - Oral	125 MCG	12/31/1989
TRIPHASIL 21 TAB	wyeth ltd.	00782416	Tablet - Oral	50 MCG	12/31/1989

CIMA AEMPS Drug Approvals

View More CIMA AEMPS Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
KYLEENA 19,5 MG SISTEMA DE LIBERACION INTRAUTERINO	Bayer Hispania S.L.	81418	SISTEMA DE LIBERACIÓN INTRAUTERINO	Diagnóstico Hospitalario	Commercialized
AILEVA 0,1 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Laboratorios Cinfa S.A.	82082	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
MICROGYNON 0,15mg/0,03mg COMPRIMIDOS RECUBIERTOS	Bayer Plc	PL00010-0545	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LOETTE DIARIO 100/20 microgramos COMPRIMIDOS RECUBIERTOS CON PELICULA	Wyeth Farma S.A.	66628	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
LEVONORGESTREL/ETINILESTRADIOL DIARIO DURBAN 0,1 MG/0,02 MG COMPRIMIDOS RECUBIERTOS EFG	Laboratorios Francisco Durban S.A.	82943	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
LEVONORGESTREL AUROVITAS 1,5 MG COMPRIMIDO EFG	Eugia Pharma (Malta) Limited	78586	COMPRIMIDO	Sin Receta	Commercialized
ANAOMI 0,1 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Sandoz Farmaceutica S.A.	77525	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
MOONBELL 1,5 MG COMPRIMIDOS EFG	Bausch Health Ireland Limited	79530	COMPRIMIDO RECUBIERTO CON PELÍCULA	Sin Receta	Not Commercialized
LEVONORGESTREL/ETINILESTRADIOL ARISTO 0.1 MG/0.02 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Aristo Pharma Iberia S.L.	84446	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ANAOMI DIARIO 0,1 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Sandoz Farmaceutica S.A.	77522	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

View More Philippines FDA Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

View More Saudi SFDA Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

View More Malaysia NPRA Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

View More UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.