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

Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders

Phase 4
Conditions
Pregnancy Early
Miscarriage
Ovarian Hyperstimulation Syndrome
Interventions
First Posted Date
2021-03-15
Last Posted Date
2021-04-01
Lead Sponsor
Assaf-Harofeh Medical Center
Target Recruit Count
100
Registration Number
NCT04797338
Locations
🇮🇱

Shamir Medical center, Be'er Ya'aqov, Israel

Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles

Phase 4
Completed
Conditions
Frozen Embryo Transfer
Dydrogesterone
Hormone Replacement Therapy
Infertility, Female
Interventions
First Posted Date
2021-02-17
Last Posted Date
2024-06-14
Lead Sponsor
CRG UZ Brussel
Target Recruit Count
150
Registration Number
NCT04758871
Locations
🇧🇪

Brussels IVF, Brussels, Belgium

Pharmacokinetics of Progesterone in Pregnancy-2

Phase 1
Terminated
Conditions
Pregnancy Related
Interventions
First Posted Date
2021-02-15
Last Posted Date
2022-05-26
Lead Sponsor
Thomas Jefferson University
Target Recruit Count
3
Registration Number
NCT04753957
Locations
🇺🇸

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

Phase 4
Completed
Conditions
Twin Pregnancy With Antenatal Problem
Interventions
First Posted Date
2021-02-10
Last Posted Date
2021-02-10
Lead Sponsor
Ain Shams University
Target Recruit Count
100
Registration Number
NCT04748562
Locations
🇪🇬

Ain Shams University Maternity hospital, Cairo, Egypt

the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes

Completed
Conditions
Female Infertility
Frozen-thawed Embryo Transfer
Infertility
Interventions
First Posted Date
2021-02-02
Last Posted Date
2023-01-03
Lead Sponsor
Akdeniz University
Target Recruit Count
205
Registration Number
NCT04733235
Locations
🇹🇷

Akdeniz University, Antalya, Turkey

Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

Phase 4
Recruiting
Conditions
Long QT Syndrome
Abnormalities, Drug-Induced
Interventions
First Posted Date
2020-12-19
Last Posted Date
2025-01-10
Lead Sponsor
Indiana University
Target Recruit Count
83
Registration Number
NCT04675788
Locations
🇺🇸

Indiana Clinical Research Center, Indianapolis, Indiana, United States

🇺🇸

Purdue University, Indianapolis, Indiana, United States

🇺🇸

Indiana University, Indianapolis, Indiana, United States

Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion

Early Phase 1
Recruiting
Conditions
PCOS
Polycystic Ovary Syndrome
Interventions
First Posted Date
2020-10-22
Last Posted Date
2023-11-02
Lead Sponsor
University of Virginia
Target Recruit Count
10
Registration Number
NCT04597099
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

Low Dose Prednisone Therapy in Women With Recurrent Pregnancy Loss

Phase 2
Conditions
Recurrent Pregnancy Loss(RPL)
Recurrent Miscarriage
Interventions
Drug: Prednisone
Drug: Progesterone
Dietary Supplement: vit D
Dietary Supplement: Iron Supplement
Dietary Supplement: Folic Acid
First Posted Date
2020-09-22
Last Posted Date
2020-09-22
Lead Sponsor
Soroka University Medical Center
Target Recruit Count
242
Registration Number
NCT04558268
Locations
🇮🇱

Soroka Medical Center, Be'er Sheva, Israel

Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders

Phase 3
Completed
Conditions
Infertility, Female
Interventions
First Posted Date
2020-09-03
Last Posted Date
2022-02-17
Lead Sponsor
El Shatby University Hospital for Obstetrics and Gynecology
Target Recruit Count
90
Registration Number
NCT04537078
Locations
🇪🇬

Elshatby University Maternity Hospital, Alexandria, Egypt

The Outcome of Two Protocols Used to Prepare Endometrium for Frozen Embryo Transfer

Phase 4
Completed
Conditions
Infertility
Infertility, Female
Infertility, Male
Interventions
First Posted Date
2020-08-10
Last Posted Date
2022-04-27
Lead Sponsor
Rahem Fertility Center
Target Recruit Count
112
Registration Number
NCT04507022
Locations
🇪🇬

Rahem Fertility Center, Zagazig, Sharkia, Egypt

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