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Jadelle (LEVONORGESTREL)
Jadelle works by binding to the progesterone receptor, which helps to prevent ovulation and thicken cervical mucus to prevent sperm from reaching the egg.
Jadelle is a progestin contraceptive implant that targets the progesterone receptor. Originally developed by Wyeth Pharmaceuticals, it is now owned by Fdn Consumer. Jadelle is a small molecule modality with a 94% bioavailability and a half-life of 9.4 hours. It is FDA-approved for various indications, including contraception, dysmenorrhea, and menopausal flushing. As an off-patent medication, it is available from multiple generic manufacturers.
At a glance
| Generic name | LEVONORGESTREL |
|---|---|
| Sponsor | Fdn Consumer |
| Drug class | Progestin |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | FDA-approved |
| First approval | 1968 |
Mechanism of action
The local mechanism by which continuously released LNG contributes to the contraceptive effectiveness of Skyla has not been conclusively demonstrated. Studies of Skyla and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium.
Approved indications
- Contraception
- Controlled ovarian stimulation
- Dysmenorrhea
- Menopausal flushing
- Menorrhagia
- Postcoital contraception
- Postmenopausal osteoporosis
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Iclevia, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Iclevia is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 5.1 )
Common side effects
- Nausea
- Abdominal Pain
- Fatigue
- Headache
- Heavier Menstrual Bleeding
- Lighter Menstrual Bleeding
- Dizziness
- Breast Tenderness
- Other complaints
- Vomiting
- Diarrhea
Drug interactions
- artemether
- atazanavir
- darunavir
- fosamprenavir
- fosphenytoin
- mephenytoin
- modafinil
- nelfinavir
- nevirapine
- oxcarbazepine
- phenobarbital
- phenytoin
Key clinical trials
- Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment (NA)
- SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer
- A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia (PHASE2)
- Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia (PHASE2,PHASE3)
- A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause (PHASE1)
- Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months (PHASE3)
- Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel (PHASE3)
- A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 10028858 | 2034-03-22 | Formulation |
| 11850182 | 2029-09-14 | Formulation |
| 11090186 | 2033-10-24 | Method of Use |
| 10561524 | 2029-09-16 | Method of Use |
| 12004992 | 2033-10-06 | Compound |
| 11571328 | 2040-09-07 | Formulation |
| 11628088 | 2027-02-07 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |