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
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
Associated Therapies
Emergency Contraception

Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"

Phase 2
Conditions
Missed Menstrual Period
Interventions
First Posted Date
2020-12-21
Last Posted Date
2021-08-12
Lead Sponsor
Gynuity Health Projects
Target Recruit Count
139
Registration Number
NCT04676776
Locations
🇲🇽

Cuidado Integral de la Mujer, Gineclinic, S.C, Mexico City, Mexico

Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product

First Posted Date
2020-01-18
Last Posted Date
2021-02-10
Lead Sponsor
Laboratorios Andromaco S.A.
Target Recruit Count
30
Registration Number
NCT04230070
Locations
🇨🇱

Innolab, Santiago, Chile

Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product

First Posted Date
2019-12-11
Last Posted Date
2021-02-10
Lead Sponsor
Laboratorios Andromaco S.A.
Target Recruit Count
10
Registration Number
NCT04194905
Locations
🇨🇱

Innolab, Santiago, Chile

A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

Phase 1
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2019-10-29
Last Posted Date
2020-03-04
Lead Sponsor
Assembly Biosciences
Target Recruit Count
80
Registration Number
NCT04142762
Locations
🇺🇸

Celerion, Tempe, Arizona, United States

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

Completed
Conditions
Pregnancy Related
First Posted Date
2019-08-16
Last Posted Date
2021-11-05
Lead Sponsor
Camber Collective
Target Recruit Count
1980
Registration Number
NCT04058873
Locations
🇬🇭

Marie Stopes International Ghana, Accra, Ghana

Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy

Phase 2
Completed
Conditions
Tuberculosis
HIV Infections
Interventions
First Posted Date
2019-01-28
Last Posted Date
2021-12-27
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
122
Registration Number
NCT03819114
Locations
🇺🇸

Hosp. of the Univ. of Pennsylvania CRS (6201), Philadelphia, Pennsylvania, United States

🇺🇸

Trinity Health and Wellness Center CRS (31443), Dallas, Texas, United States

🇺🇸

2701 Northwestern University CRS, Chicago, Illinois, United States

and more 15 locations

Contraceptive Hormones, Immunity, and Microbiome Evaluation

Completed
Conditions
Hormonal Contraception
Interventions
First Posted Date
2018-09-06
Last Posted Date
2024-10-29
Lead Sponsor
Emory University
Target Recruit Count
155
Registration Number
NCT03660046
Locations
🇺🇸

Grady Health System, Atlanta, Georgia, United States

🇺🇸

The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE, Atlanta, Georgia, United States

🇺🇸

Atlanta Women's Center, Atlanta, Georgia, United States

Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Early Phase 1
Completed
Conditions
Contraception
Interventions
First Posted Date
2018-09-05
Last Posted Date
2023-04-25
Lead Sponsor
University of Oklahoma
Target Recruit Count
28
Registration Number
NCT03657602
Locations
🇺🇸

University of Oklahoma - Tulsa, Tulsa, Oklahoma, United States

Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

Phase 2
Completed
Conditions
Emergency Contraception
Interventions
First Posted Date
2018-08-03
Last Posted Date
2024-05-06
Lead Sponsor
Dr. Hang Wun Raymond Li
Target Recruit Count
860
Registration Number
NCT03614494
Locations
🇭🇰

The Family Planning Association of Hong Kong, Hong Kong, Hong Kong

🇭🇰

Queen Mary Hospital, Hong Kong, Hong Kong

Darunavir and Rilpivirine Interactions With Levonorgestrel Implant

Phase 2
Conditions
HIV-1-infection
Contraception
Interventions
First Posted Date
2018-07-17
Last Posted Date
2019-03-28
Lead Sponsor
Makerere University
Target Recruit Count
60
Registration Number
NCT03589027
Locations
🇺🇬

Infectious Diseases Institue, Kampala, Uganda

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