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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

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Phase 3
Completed
Conditions
In Vitro Fertilization
Interventions
First Posted Date
2009-01-23
Last Posted Date
2013-01-31
Lead Sponsor
IBSA Institut Biochimique SA
Target Recruit Count
683
Registration Number
NCT00827983
Locations
🇨🇭

IIRM SA, Sorengo, Ticino, Switzerland

🇨🇭

Universitätsfrauenklinik Basel, Basel, Switzerland

🇭🇺

First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine, Budapest, Hungary

and more 11 locations

Progesterone for the Treatment of Traumatic Brain Injury III

Phase 3
Terminated
Conditions
Traumatic Brain Injury
Interventions
Drug: Placebo
First Posted Date
2009-01-15
Last Posted Date
2016-01-20
Lead Sponsor
David Wright
Target Recruit Count
882
Registration Number
NCT00822900
Locations
🇺🇸

North Memorial Hospital, Robbinsdale, Minnesota, United States

🇺🇸

Regional Medical Center-San Jose, San Jose, California, United States

🇺🇸

Grady Memorial Hospital, Atlanta, Georgia, United States

and more 33 locations

17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

First Posted Date
2008-12-17
Last Posted Date
2011-08-30
Lead Sponsor
Meir Medical Center
Target Recruit Count
800
Registration Number
NCT00809939
Locations
🇮🇱

Meir Medical Center, Kfar Saba, Israel

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

First Posted Date
2008-12-10
Last Posted Date
2012-01-27
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
110
Registration Number
NCT00805935
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

🇺🇸

Women & Infants' Hospital of RI, Providence, Rhode Island, United States

🇺🇸

Conceptions Reproductive Associates of Colorado, Littleton, Colorado, United States

and more 3 locations

Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Not Applicable
Completed
Conditions
Polycystic Ovary Syndrome (PCOS)
Obstructive Sleep Apnea
Obesity
Interventions
Device: continuous positive airway pressure
Other: Control
First Posted Date
2008-12-09
Last Posted Date
2018-08-01
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
61
Registration Number
NCT00805207
Locations
🇺🇸

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

MENOPUR® Versus FOLLISTIM®

Phase 4
Completed
Conditions
Infertility
Interventions
First Posted Date
2008-12-04
Last Posted Date
2011-11-02
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
173
Registration Number
NCT00802360
Locations
🇺🇸

A Woman's Center for Reproductive Medicine, Baton Rouge, Louisiana, United States

🇺🇸

Huntington Reproductive Center, Pasadena, California, United States

🇺🇸

Women's Medical Research Group, LLC, Clearwater, Florida, United States

and more 4 locations

Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women

Phase 4
Completed
Conditions
Hormone Replacement
Interventions
First Posted Date
2008-09-19
Last Posted Date
2011-07-22
Lead Sponsor
Medical University of Vienna
Target Recruit Count
30
Registration Number
NCT00755963
Locations
🇦🇹

Medical University of Vienna, Dept. of Psychiatry and Psychotherapy, Vienna, Austria

Low Molecular Weight Heparin in Recurrent Implantation Failure

Not Applicable
Completed
Conditions
Infertility
Fertilization in Vitro
Recurrent Implantation Failure
Interventions
Drug: low molecular weight heparin (enoxaparine sodium)
First Posted Date
2008-09-10
Last Posted Date
2009-03-20
Lead Sponsor
V.K.V. American Hospital, Istanbul
Registration Number
NCT00750451
Locations
🇹🇷

Assisted Reproduction Unit of the American Hospital of Istanbul, Istanbul, Turkey

Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

Not Applicable
Terminated
Conditions
Preeclampsia
Interventions
Drug: Placebo Oral Tablet
First Posted Date
2008-07-21
Last Posted Date
2017-04-17
Lead Sponsor
John Uckele
Target Recruit Count
3
Registration Number
NCT00719537
Locations
🇺🇸

William Beaumont Hospital, Royal Oak, Michigan, United States

A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.

Phase 4
Conditions
IVF - Luteal Phase Support After Embryo Transfer
Interventions
First Posted Date
2008-07-02
Last Posted Date
2008-07-02
Lead Sponsor
Nordica Fertility Clinic
Target Recruit Count
2686
Registration Number
NCT00708539
Locations
🇸🇪

Reproduktionscentrum, Sahlgrenska, Göteborg, Sweden

🇸🇪

Reproduktionscentrum, Stockholm, Sweden

🇸🇪

Norrlandsuniversitets sjukhus, Umeå, Sweden

and more 14 locations
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