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

A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore

Phase 2
Conditions
Endometrial Hyperplasia
Fertility Issues
Disease Regression
Treatment Side Effects
Interventions
First Posted Date
2022-08-08
Last Posted Date
2022-08-08
Lead Sponsor
KK Women's and Children's Hospital
Target Recruit Count
60
Registration Number
NCT05492487
Locations
🇸🇬

Singapore General Hospital, Singapore, Singapore

🇸🇬

National University Hospital, Singapore, Singapore

🇸🇬

KK Women's and Children's Hospital, Singapore, Singapore

Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start

Phase 4
Recruiting
Conditions
Contraception
Interventions
First Posted Date
2022-07-06
Last Posted Date
2024-05-08
Lead Sponsor
University of Utah
Target Recruit Count
1404
Registration Number
NCT05444582
Locations
🇺🇸

Planned Parenthood Illinoi, Chicago, Illinois, United States

🇺🇸

Planned Parenthood League of Massachusetts, Boston, Massachusetts, United States

🇺🇸

Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky, Seattle, Washington, United States

and more 5 locations

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

Phase 1
Completed
Conditions
Therapeutic Equivalency
Interventions
First Posted Date
2022-03-16
Last Posted Date
2022-06-02
Lead Sponsor
Laboratorios Andromaco S.A.
Target Recruit Count
36
Registration Number
NCT05282940
Locations
🇮🇳

Azidus Laboratories Ltd., Chennai, Tamil Nadu, India

STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS

First Posted Date
2021-10-26
Last Posted Date
2024-08-19
Lead Sponsor
Pfizer
Target Recruit Count
35
Registration Number
NCT05093205
Locations
🇺🇸

Anaheim Clinical Trials, LLC, Anaheim, California, United States

Kuwa Free! - Live Free!

Not Applicable
Recruiting
Conditions
HIV Infections
Contraception
Drug-drug Interaction
Interventions
Drug: NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens
Drug: Intramuscular depo-medroxyprogesterone acetate (IM DMPA)
First Posted Date
2021-09-16
Last Posted Date
2025-04-10
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
700
Registration Number
NCT05044962
Locations
🇰🇪

Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH), Eldoret, Kenya

Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

Phase 4
Active, not recruiting
Conditions
Human Immunodeficiency Virus
Contraception
ART
Interventions
Drug: Depo medroxyprogesterone acetate injection
First Posted Date
2021-06-02
Last Posted Date
2023-07-27
Lead Sponsor
Botswana Harvard AIDS Institute Partnership
Target Recruit Count
140
Registration Number
NCT04910711
Locations
🇧🇼

Princess Marina Hospital, Gaborone, Botswana

Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia

Phase 3
Withdrawn
Conditions
Endometrial Hyperplasia
Interventions
First Posted Date
2021-05-21
Last Posted Date
2023-07-05
Lead Sponsor
Wake Forest University Health Sciences
Registration Number
NCT04897217

Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele

Not Applicable
Completed
Conditions
Isthmocele
Pelvic Pain
Post-menstrual Spotting Bleeding
Interventions
Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele
First Posted Date
2021-05-04
Last Posted Date
2021-08-25
Lead Sponsor
Gaziosmanpasa Research and Education Hospital
Target Recruit Count
30
Registration Number
NCT04872244
Locations
🇹🇷

saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital, Istanbul, Turkey

Impact of Contraceptives on Cervico-Vaginal Mucosa

Phase 4
Completed
Conditions
Contraceptive; Complications, Intrauterine
Mucosal Inflammation
Interventions
First Posted Date
2021-03-24
Last Posted Date
2023-08-25
Lead Sponsor
Eastern Virginia Medical School
Target Recruit Count
112
Registration Number
NCT04814927
Locations
🇺🇸

Eastern Virginia Medical School, Norfolk, Virginia, United States

🇰🇪

KEMRI, Thika, Central, Kenya

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

Completed
Conditions
Hormonal Intrauterine Contraception
Interventions
First Posted Date
2021-03-08
Last Posted Date
2023-06-15
Lead Sponsor
Bayer
Target Recruit Count
316
Registration Number
NCT04785950
Locations
🇪🇸

Many locations, Multiple Locations, Spain

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