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

Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved(Frozen)-Thawed Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone.

First Posted Date
2014-01-10
Last Posted Date
2019-09-27
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
300
Registration Number
NCT02032797
Locations
🇧🇪

Centre of Reproductive Medicine CRG, Jette, Brussels, Belgium

A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2013-12-24
Last Posted Date
2018-05-08
Lead Sponsor
TherapeuticsMD
Target Recruit Count
6
Registration Number
NCT02019589
Locations
🇺🇸

The Woman's Hospital of Texas Clinical Research Center, Houston, Texas, United States

🇺🇸

Precision Clinical Trials/Arizona Wellness Center for Women, Phoenix, Arizona, United States

🇺🇸

Precision Trials/New Horizons Women's Care, Chandler, Arizona, United States

and more 18 locations

Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial

Phase 2
Conditions
Interventions
First Posted Date
2013-11-15
Last Posted Date
2013-11-15
Lead Sponsor
nor zila hassan malek
Target Recruit Count
32
Registration Number
NCT01985594
Locations
🇲🇾

Obstetric and Gynaecology Department, National University of Malaysia Medical Centre, Cheras, Kuala Lumpur, Malaysia

Progesterone for Smoking Relapse Prevention Following Delivery

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-10-30
Last Posted Date
2018-01-17
Lead Sponsor
Yale University
Target Recruit Count
41
Registration Number
NCT01972464
Locations
🇺🇸

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

Progesterone and Brain Imaging Study

First Posted Date
2013-10-07
Last Posted Date
2022-07-05
Lead Sponsor
University of Pennsylvania
Target Recruit Count
81
Registration Number
NCT01954966
Locations
🇺🇸

Penn Center for Women's Behavioral Wellness, Philadelphia, Pennsylvania, United States

A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-09-16
Last Posted Date
2019-05-06
Lead Sponsor
TherapeuticsMD
Target Recruit Count
1845
Registration Number
NCT01942668
Locations
🇺🇸

Accelovance, Melbourne, Florida, United States

🇺🇸

Clinical Research of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

Radiant Research (Chicago), Chicago, Illinois, United States

and more 114 locations

Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved (Frozen)-Thawed Day 3 Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-09-12
Last Posted Date
2019-09-27
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
300
Registration Number
NCT01940653
Locations
🇧🇪

UZ Brussel, Brussels, Belgium

Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening

First Posted Date
2013-08-27
Last Posted Date
2015-10-30
Lead Sponsor
Indiana University
Target Recruit Count
19
Registration Number
NCT01929083
Locations
🇺🇸

Indiana Clinical Research Center, Indianapolis, Indiana, United States

🇺🇸

Purdue University, Indianapolis, Indiana, United States

Preterm Delivery Prevention in Twins With Progesterone

Phase 4
Conditions
Interventions
First Posted Date
2013-08-21
Last Posted Date
2013-08-21
Lead Sponsor
Universidad del Desarrollo
Target Recruit Count
213
Registration Number
NCT01927029

Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist

First Posted Date
2013-06-28
Last Posted Date
2013-06-28
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
120
Registration Number
NCT01888744
Locations
🇧🇪

Centre for Reproductive Medicine, Brussels, Belgium

© Copyright 2024. All Rights Reserved by MedPath