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
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
Associated Therapies
Assisted Reproductive Technology therapy

Progesterone for Postpartum Cocaine Relapse

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2010-11-29
Last Posted Date
2017-03-28
Lead Sponsor
Yale University
Target Recruit Count
50
Registration Number
NCT01249274
Locations
🇺🇸

Yale School of Medicine, New Haven, Connecticut, United States

Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)

First Posted Date
2010-10-21
Last Posted Date
2014-03-14
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
124
Registration Number
NCT01225835
Locations
🇩🇪

IVF Zentrum, Saar, Germany

🇩🇪

Endokrinologikum Ulm, Ulm, Germany

🇩🇪

Fertility Center Berlin, Berlin, Germany

and more 5 locations

Progestagens for the Tertiary Prophylaxis of Preterm Delivery

First Posted Date
2010-08-10
Last Posted Date
2016-09-23
Lead Sponsor
University of Modena and Reggio Emilia
Target Recruit Count
254
Registration Number
NCT01178788
Locations
🇮🇹

University of Modena and Reggio Emilia, Modena, Italy

Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-08-05
Last Posted Date
2011-10-13
Lead Sponsor
Productos Científicos S. A. de C. V.
Target Recruit Count
48
Registration Number
NCT01176175
Locations
🇲🇽

Asociación Mexicana para la Investigación Clínica, A. C. (AMIC), Pachuca, Hidalgo, Mexico

Sex Hormones and Orthostatic Tolerance

First Posted Date
2010-06-30
Last Posted Date
2018-12-13
Lead Sponsor
Yale University
Target Recruit Count
109
Registration Number
NCT01153581
Locations
🇺🇸

John B. Pierce Laboratory, New Haven, Connecticut, United States

Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-06-22
Last Posted Date
2013-07-03
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
200
Registration Number
NCT01147770

Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

First Posted Date
2010-06-14
Last Posted Date
2024-10-02
Lead Sponsor
BHR Pharma, LLC
Target Recruit Count
1195
Registration Number
NCT01143064
Locations
🇺🇸

University of South Alabama Medical Center, Mobile, Alabama, United States

🇺🇸

LAC+USC Medical Center, Los Angeles, California, United States

🇺🇸

University of California San Diego Medical Center, San Diego, California, United States

and more 153 locations

Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

First Posted Date
2010-05-14
Last Posted Date
2011-11-03
Lead Sponsor
University Hospital of North Norway
Target Recruit Count
40
Registration Number
NCT01123538
Locations
🇳🇴

Gynecology center, Helse Nord, Bodø, Norway

Lutropin Alfa in Women at Risk of Poor Response

First Posted Date
2010-04-28
Last Posted Date
2018-08-28
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
58
Registration Number
NCT01112358
Locations
🇪🇸

Hospital Universitario de La Fe, Valencia, Spain

A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-03-05
Last Posted Date
2014-07-31
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
238
Registration Number
NCT01081652
Locations
🇨🇳

Peking University 3rd Hopistal, Beijing, China

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