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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

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Title
Posted
Study ID
Phase
Status
Sponsor
2024/10/08
Phase 1
Not yet recruiting
2024/09/24
Phase 4
Recruiting
2024/08/27
Phase 3
Not yet recruiting
2024/06/18
Not Applicable
Recruiting
Mỹ Đức Hospital
2023/10/19
Phase 3
Completed
2023/08/22
Not Applicable
Recruiting
Nanjing University
2023/08/18
Phase 4
Recruiting
2023/08/08
Phase 2
Not yet recruiting
Beijing Tiantan Hospital
2023/08/07
Phase 1
Recruiting
2023/08/01
Phase 1
Recruiting

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Direct Rx
72189-347
ORAL
200 mg in 1 1
4/27/2022
Actavis Pharma, Inc.
0591-3128
INTRAMUSCULAR
50 mg in 1 mL
10/5/2022
Columbia Laboratories, Inc.
55056-0806
VAGINAL
90 mg in 1.125 g
11/19/2009
Bryant Ranch Prepack
71335-1432
ORAL
200 mg in 1 1
7/14/2023
Mayne Pharma
68308-751
ORAL
100 mg in 1 1
11/28/2023
NuCare Pharmaceuticals,Inc.
68071-2768
ORAL
100 mg in 1 1
6/15/2023
Proficient Rx LP
71205-669
ORAL
200 mg in 1 1
6/1/2022
Banner Pharmacaps
10888-7136
ORAL
200 mg in 1 1
11/22/2013
NuCare Pharmaceuticals,Inc.
68071-2770
ORAL
200 mg in 1 1
7/15/2022
RPK Pharmaceuticals, Inc.
53002-2760
ORAL
200 mg in 1 1
6/6/2022

EMA Drug Approvals

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

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Progesterone Soft Capsules
国药准字H20254199
化学药品
胶囊剂
5/20/2025
Progesterone Soft Capsules
国药准字H20254198
化学药品
胶囊剂
5/20/2025
Progesterone Soft Capsules
国药准字H20254091
化学药品
胶囊剂
5/13/2025
Progesterone Soft Capsules
国药准字H20254090
化学药品
胶囊剂
5/13/2025
Progesterone Injection(II)
国药准字H20253626
化学药品
注射剂
3/18/2025
Progesterone Injection(II)
国药准字H20244091
化学药品
注射剂
6/18/2024
Progesterone Injection
国药准字H42021920
化学药品
注射剂
7/6/2022
Progesterone Injection
国药准字H41021493
化学药品
注射剂
6/5/2020
Progesterone Injection
国药准字H20205021
化学药品
注射剂
8/20/2020
Progesterone Injection
国药准字H53020916
化学药品
注射剂
9/28/2020

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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