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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

Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial

Phase 3
Completed
Conditions
Preterm Birth
Pregnancy Trimester, Second
First Posted Date
2007-01-17
Last Posted Date
2007-01-17
Lead Sponsor
King's College Hospital NHS Trust
Target Recruit Count
250
Registration Number
NCT00422526
Locations
🇨🇱

Hospital Clinico Universidad de Chile, Santiago, Chile

🇬🇷

University Hospital, Larissa, Greece

🇬🇧

Darent Valley Hospital, Kent, United Kingdom

and more 5 locations

Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
First Posted Date
2006-09-19
Last Posted Date
2006-09-20
Lead Sponsor
IBSA Institut Biochimique SA
Target Recruit Count
24
Registration Number
NCT00377923

Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Not Applicable
Completed
Conditions
Preterm Birth
Interventions
First Posted Date
2006-06-22
Last Posted Date
2013-08-15
Lead Sponsor
University of Calgary
Target Recruit Count
84
Registration Number
NCT00343265
Locations
🇨🇦

Calgary Health Region, Calgary, Alberta, Canada

Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Phase 2
Completed
Conditions
Preterm Delivery
Interventions
Drug: Placebo
First Posted Date
2006-05-25
Last Posted Date
2011-07-25
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
677
Registration Number
NCT00329914
Locations
🇩🇰

Glostrup Hospital, Glostrup, Denmark

🇩🇰

Holbaek Hospital, Holbaek, Denmark

🇩🇰

Hvidovre Hospital, Hvidovre, Denmark

and more 14 locations

Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent

Not Applicable
Withdrawn
Conditions
Pregnancy
Premature Birth
First Posted Date
2006-05-24
Last Posted Date
2008-06-27
Lead Sponsor
The Baruch Padeh Medical Center, Poriya
Registration Number
NCT00329316

Bioidentical 'Natural' Hormone Evaluation in Early Menopause

Phase 2
Terminated
Conditions
Menopause
Interventions
First Posted Date
2006-03-14
Last Posted Date
2018-07-06
Lead Sponsor
Jeanne Drisko, MD, CNS, FACN
Target Recruit Count
21
Registration Number
NCT00302731
Locations
🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

Effect of Progesterone on Smoking Behavior in Male and Female Smokers

Phase 1
Completed
Conditions
Tobacco Use Disorder
Interventions
Drug: sugar pill
First Posted Date
2005-12-30
Last Posted Date
2020-04-02
Lead Sponsor
Yale University
Target Recruit Count
65
Registration Number
NCT00271206
Locations
🇺🇸

VA Connecticut Health Care System, New Haven, Connecticut, United States

Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II

Phase 2
Completed
Conditions
Cervical Intraepithelial Neoplasia
First Posted Date
2005-11-01
Last Posted Date
2012-03-09
Lead Sponsor
Medical University of Vienna
Target Recruit Count
40
Registration Number
NCT00247169
Locations
🇦🇹

Dept OB/GYN, Med University of Vienna, Vienna, Austria

Progesterone for the Treatment of Cocaine Dependence - 1

Not Applicable
Completed
Conditions
Cocaine Abuse
Cocaine-Related Disorders
Interventions
Other: Placebo
First Posted Date
2005-09-22
Last Posted Date
2020-10-08
Lead Sponsor
University of Minnesota
Target Recruit Count
96
Registration Number
NCT00218257
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

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