Norgestrel
- Generic Name
- Norgestrel
- Brand Names
- Cryselle 28, Elinest 28 Day, Lo/ovral 28 Day, Low-ogestrel 28 Day, Turqoz 28 Day
- Drug Type
- Small Molecule
- Chemical Formula
- C21H28O2
- CAS Number
- 6533-00-2
- Unique Ingredient Identifier
- 3J8Q1747Z2
Overview
Norgestrel is synthetic steroidal progestin that is used in combination with ethinyl estradiol for oral contraception. Norgestrel is composed of a racemic mixture of two stereoisomers, dextronorgestrel and levonorgestrel. However, only the levorotary enantiomer (levonorgestrel) is biologically active.
Background
Norgestrel is synthetic steroidal progestin that is used in combination with ethinyl estradiol for oral contraception. Norgestrel is composed of a racemic mixture of two stereoisomers, dextronorgestrel and levonorgestrel. However, only the levorotary enantiomer (levonorgestrel) is biologically active.
Indication
Norgestrel in combination with ethinyl estradiol is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Associated Conditions
- Abnormal Uterine Bleeding
- Endometriosis
- Hypermenorrhea
- Menstrual Distress (Dysmenorrhea)
- Polycystic Ovarian Syndrome (PCOS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/10/02 | Phase 3 | Completed | HRA Pharma | ||
2018/07/13 | Phase 2 | Completed | HRA Pharma | ||
2018/06/15 | Phase 3 | Terminated | HRA Pharma | ||
2003/01/27 | Phase 2 | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|
No FDA products found
No FDA products found for this drug
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|---|---|---|---|---|
PROGYLUTON TABLET | TABLET, SUGAR COATED | 0.5 mg | 1990/06/25 | SIN04778P |
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
Norgestrel Tablets | 国药准字H11022262 | 片剂 | N/A | 3mg | Chemical Drug | Approved | 2020/11/26 | Domestic | |
Norgestrel Tablets | 国药准字H11022128 | 片剂 | N/A | 3mg | Chemical Drug | Approved | 2023/11/14 | Domestic |
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|
No Australia products found
No Australia products found for this drug