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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
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

A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

Phase 3
Completed
Conditions
Infertility
Interventions
First Posted Date
2008-02-14
Last Posted Date
2013-09-13
Lead Sponsor
Duramed Research
Target Recruit Count
1297
Registration Number
NCT00615251
Locations
🇺🇸

Duramed Investigational Site, Norfolk, Virginia, United States

PREGNANT Short Cervix Trial

Phase 3
Completed
Conditions
Preterm Delivery
Short Cervix
Short Uterine Cervical Length
Interventions
Drug: placebo
First Posted Date
2008-02-14
Last Posted Date
2012-03-13
Lead Sponsor
Juniper Pharmaceuticals, Inc.
Target Recruit Count
465
Registration Number
NCT00615550
Locations
🇺🇸

Johns Hopkins Community Physicians, Baltimore, Maryland, United States

🇺🇸

University of Miami Leonard Miller School of Medicine Department of Obstetrics and Gynecology, Miami, Florida, United States

🇺🇸

Caritas St. Elizabeth's Medical Center, Boston, Massachusetts, United States

and more 46 locations

Determining How Quickly Progesterone Slows LH Pulse Frequency

Phase 1
Completed
Conditions
PCOS
Normal
Interventions
First Posted Date
2008-01-15
Last Posted Date
2025-03-28
Lead Sponsor
University of Virginia
Target Recruit Count
85
Registration Number
NCT00594217
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues

Phase 1
Completed
Conditions
Cocaine Dependence
Interventions
Drug: Placebo
First Posted Date
2008-01-03
Last Posted Date
2014-02-12
Lead Sponsor
Yale University
Target Recruit Count
60
Registration Number
NCT00585520
Locations
🇺🇸

Yale University School of Medicine: Research Program on Stress, Addiction, and Psychopathology, New Haven, Connecticut, United States

Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Not Applicable
Completed
Conditions
Infant, Premature
Premature Birth
Interventions
First Posted Date
2007-12-24
Last Posted Date
2021-05-19
Lead Sponsor
University of Oklahoma
Target Recruit Count
174
Registration Number
NCT00579553
Locations
🇺🇸

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism

Not Applicable
Terminated
Conditions
Postmenopausal Syndrome
Interventions
First Posted Date
2007-11-30
Last Posted Date
2018-10-16
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
22
Registration Number
NCT00565916
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Phase 3
Terminated
Conditions
Preterm Delivery
Morbidity
Perinatal Mortality
Interventions
Drug: placebo
First Posted Date
2007-09-27
Last Posted Date
2012-06-06
Lead Sponsor
begoña Martinez de Tejada
Target Recruit Count
384
Registration Number
NCT00536003
Locations
🇨🇭

University Hospital Zürich, Zurich, Switzerland

🇨🇭

Universitäts-Frauenklinik Kantonespital Basel, Basel, Switzerland

🇨🇭

Kantonales Frauenspital Chur, Chur, Switzerland

and more 30 locations

Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women

Phase 4
Completed
Conditions
Healthy
Postmenopausal
First Posted Date
2007-09-17
Last Posted Date
2007-09-17
Lead Sponsor
Max-Planck-Institute of Psychiatry
Target Recruit Count
10
Registration Number
NCT00530582
Locations
🇩🇪

Max Planck Institute of Psychiatry, Munich, Bavaria, Germany

Postmenopausal Women Estrogen and Progesterone Infusion

Phase 1
Completed
Conditions
Postmenopause
Aging
Interventions
First Posted Date
2007-04-04
Last Posted Date
2018-05-18
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
20
Registration Number
NCT00455741
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Effect of Race on Gonadotropin Responses

Phase 1
Completed
Conditions
Premenopause
Healthy
Interventions
First Posted Date
2007-04-04
Last Posted Date
2017-07-27
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
23
Registration Number
NCT00455962
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

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