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
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 Maintenance Tocolysis: A Randomized Placebo Controlled Trial

Phase 2
Terminated
Conditions
Pregnancy Complications
Interventions
Drug: Progesterone
Drug: Polyethylene glycol&hydrogenated vegetable oil.
First Posted Date
2009-07-24
Last Posted Date
2017-03-16
Lead Sponsor
Stanford University
Target Recruit Count
7
Registration Number
NCT00946088
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

PP13 and Doppler Study to Predict Preeclampsia

Phase 2
Conditions
Preeclampsia
Interventions
Drug: No Drug
Drug: Low molecular weight Heparin
Drug: Progesterone
First Posted Date
2009-06-25
Last Posted Date
2009-06-25
Lead Sponsor
Ben-Gurion University of the Negev
Target Recruit Count
1000
Registration Number
NCT00928213
Locations
🇮🇱

Soroka Medical Center, Ben Gurion University, Beer-Sheva, Israel

Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

Phase 2
Conditions
Endometrial Hyperplasia
Endometrial Cancer
Interventions
Drug: activella
Drug: progesterone
First Posted Date
2009-06-12
Last Posted Date
2009-06-12
Lead Sponsor
Rabin Medical Center
Target Recruit Count
60
Registration Number
NCT00919919
Locations
🇮🇱

Rabin Medical Center Beilinson Hospital, Petach Tikva, Israel

Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in 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
800
Registration Number
NCT00828191
Locations
🇺🇸

Idaho Center for Reproductive Medicine, Boise, Idaho, United States

🇺🇸

Center for Assisted Reproduction, Bedford, Texas, United States

🇺🇸

Seattle Reproductive Medicine, Seattle, Washington, United States

and more 5 locations

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
Drug: Progesterone
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

Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Not Applicable
Completed
Conditions
Polycystic Ovary Syndrome (PCOS)
Obstructive Sleep Apnea
Obesity
Interventions
Drug: Progesterone
Drug: testosterone
Device: continuous positive airway pressure
Drug: glucocorticoid
Drug: Estrogen
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

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

Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

Not Applicable
Terminated
Conditions
Preeclampsia
Interventions
Drug: Aspirin
Drug: Placebo Oral Tablet
Drug: Progesterone
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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