MedPath

Progesterone

Generic Name
Progesterone
Brand Names
Bijuva, Crinone, Endometrin, Prochieve, Prometrium
Drug Type
Small Molecule
Chemical Formula
C21H30O2
CAS Number
57-83-0
Unique Ingredient Identifier
4G7DS2Q64Y

Overview

Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss . Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization , as well as in other formulations to promote and support pregnancy. Please see Medroxyprogesterone acetate, Megestrol acetate, Dydrogesterone and Hydroxyprogesterone entries for information on various other forms of progesterone. Pharmaceutical progesterone is made from a plant source as a starting material and is chemically identical to progesterone of human ovarian origin . Progesterone is available in gelatinized capsule form, vaginal gel form, tablet form, vaginal insert form, and injection form, all used for various purposes .

Background

Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss . Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization , as well as in other formulations to promote and support pregnancy. Please see Medroxyprogesterone acetate, Megestrol acetate, Dydrogesterone and Hydroxyprogesterone entries for information on various other forms of progesterone. Pharmaceutical progesterone is made from a plant source as a starting material and is chemically identical to progesterone of human ovarian origin . Progesterone is available in gelatinized capsule form, vaginal gel form, tablet form, vaginal insert form, and injection form, all used for various purposes .

Indication

Gelatinized capsules The gelatinized capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea . Vaginal gel Progesterone gel (8%) is indicated as progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. The lower concentration progesterone gel (4%) is used in the treatment of secondary amenorrhea, with the use of the 8% concentration if there is no therapeutic response to the 4% gel . Vaginal insert This form is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women . Injection (intramuscular) This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer . Tablets, contraceptive The tablet form of progesterone in contraceptive formulations is indicated for the prevention of pregnancy .

Associated Conditions

  • Abnormal Uterine Bleeding
  • Amenorrhea
  • Endometrial hyperplasia caused by conjugated estrogen
  • Moderate to Severe Vasomotor Symptoms
  • Pregnancy
  • Secondary Amenorrhea
  • Recurrent spontaneous preterm birth

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/16
Not Applicable
Active, not recruiting
Dr. Soetomo General Hospital
2025/04/15
Not Applicable
Recruiting
The General Authority for Teaching Hospitals and Institutes
2025/03/13
Phase 4
Not yet recruiting
Dunamenti REK Istenhegyi IVF Center
2025/03/11
Early Phase 1
Not yet recruiting
2025/03/04
Phase 4
Not yet recruiting
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
2025/02/28
Early Phase 1
Recruiting
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2025/02/19
Phase 4
Not yet recruiting
Children's Mercy Hospital Kansas City
2025/02/06
N/A
Completed
El Shatby University Hospital for Obstetrics and Gynecology
2025/02/04
Phase 2
Recruiting
2024/11/01
Phase 1
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bryant Ranch Prepack
71335-1990
ORAL
200 mg in 1 1
1/8/2021
Bryant Ranch Prepack
71335-1443
ORAL
100 mg in 1 1
5/20/2021
Dr. Donna Restivo DC
62185-0050
ORAL
8 [hp_X] in 1 mL
5/23/2025
West-Ward Pharmaceuticals Corp
0143-9725
INTRAMUSCULAR
50 mg in 1 1
9/17/2018
Columbia Laboratories, Inc.
55056-0818
VAGINAL
90 mg in 1.125 g
11/19/2009
Asclemed USA, Inc.
76420-282
ORAL
200 mg in 1 1
9/15/2022
Asclemed USA, Inc.
76420-058
ORAL
100 mg in 1 1
10/12/2022
BioActive Nutritional, Inc.
43857-0103
ORAL
6 [hp_X] in 1 mL
5/20/2025
Sincerus Florida, LLC
72934-4149
TOPICAL
0.1 g in 100 g
5/6/2019
A-S Medication Solutions
50090-6835
ORAL
100 mg in 1 1
4/12/2021

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ENDOMETRIN VAGINAL TABLETS 100 MG
SIN15005P
TABLET, EFFERVESCENT
100.0 mg
5/12/2016
UTROGESTAN CAPSULE 100 mg (White)
SIN11437P
CAPSULE, LIQUID FILLED
100 mg
12/19/2000
CYCLOGEST PESSARY 400 mg
SIN03626P
SUPPOSITORY
400 mg
7/26/1989
CRINONE PROGESTERONE VAGINAL GEL 8%
SIN10884P
GEL
8%
4/21/1999
UTROGESTAN CAPSULE 200mg
SIN15475P
CAPSULE, LIQUID FILLED
200mg
4/30/2018

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Progesterone Suppositories
国药准字H32026636
化学药品
栓剂
7/7/2020
Progesterone Suppositories
国药准字H31022328
化学药品
栓剂
3/23/2020
Progesterone Suppositories
国药准字H42022307
化学药品
栓剂
6/29/2020
Progesterone Sustained-release vaginal gel
国药准字HJ20140552
化学药品
凝胶剂
3/20/2024
Progesterone Capsules
国药准字H20041902
化学药品
胶囊剂
7/24/2024
Progesterone Soft Capsules
国药准字H20253806
化学药品
胶囊剂
4/1/2025
Progesterone Soft Capsules
国药准字HJ20160264
化学药品
胶囊剂
3/19/2021
Progesterone Soft Capsules
国药准字HJ20160265
化学药品
胶囊剂
3/19/2021
Progesterone Soft Capsules
国药准字H20040982
化学药品
胶囊剂
1/9/2020
Progesterone Soft Capsules
国药准字H20031099
化学药品
胶囊剂
6/12/2024

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
ZESBINA 100 CAPSULES 100MG
N/A
N/A
N/A
2/15/2024
© Copyright 2025. All Rights Reserved by MedPath